284 Quality Systems Jobs - Page 12

Role & responsibilities Lead and manage the overall technical operations of the organization including Design, Manufacturing, and Overall Quality . Drive implementation and continuous improvement of Latest manufacturing technologies , with a focus on modern and cost-effective processes. Oversee the design and development of new products (NPD) , ensuring innovation, Cost efficiency, and regulatory compliance. Ensure compliance and excellence in quality management systems : ISO standards, TPM (Total Productive Maintenance) , and TQM (Total Quality Management) . Supervise and enhance SS (Stainless Steel) Fabrication processes with a focus on precision and quality. Manage vendor development , incoming quality control , and in-house quality assurance processes. Collaborate with cross-functional teams to ensure project timelines, quality standards, and cost targets are met. Provide technical leadership in software tools used for design and development (e.g., SolidWorks, AutoCAD, or similar). Industry Background Candidates must have experience in one or more of the following industries: Dairy & Hospitality Equipment Fabrication Pharmaceutical Equipment Fabrication Hospital/Healthcare Equipment Fabrication High-Quality Stainless-Steel Fabrication & Fine Finish

Responsibilities: * Develop quality procedures & documentation * Conduct internal audits as QA specialist * Ensure compliance with industry standards * Lead quality initiatives & improvements * Implement quality management systems Provident fund Annual bonus Employee state insurance

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Core Purpose of the Role : To perform the role as Clinical QA auditor to verify compliance to ICH-GCP, NDCT Rule and other applicable regulatory requirements with respect to BABE/ Phase I studies. Comfortable working and communicating professionally with others to reach understanding and agreement as necessary. Other Responsibilities: To perform or assist any other relevant job with relevant training as and when required by Department Head or Management. Role Accountabilities: To perform study specific in-process audits as per audit plan to ensure that study is conducted in compliance with in-house SOPs, protocol and applicable regulatory guidelines etc., To perform study specific retrospective audits of informed consent document, study files like TMF, case report forms, raw data forms, draft clinical study report and other applicable documents to ensure that study is conducted in compliance with in-house SOPs, protocol and applicable regulatory guidelines etc., To perform database audits in EDC application for applicable studies. To prepare and issue audit reports to respective operations team in consultation with Manager/ Department Head and follow-up the implementation of CAPA to ensure timely closure of audit observations. To initiate change control and follow-up for the same for timely closure in consultation with Manager/ Department Head. To review change control, deviation and other QMS elements taken by operations team and follow-up for its timely closure. To review draft documents like Protocol, ICD, CRF etc., before its finalization. To assist for system audit as co-auditor and or providing input to Compliance QA team, if required. To perform vendor audit as lead/ co-auditor as per vendor audit forecast plan, if required. To review qualification and validation documents, if required by Manager/ Department Head. To assist and or participate whenever required as per Department Head discretion during system audit, internal and external audits and inspection as part of audit/ inspection readiness. To assist in preparation or reviewing the CAPA whenever required during system audit, internal and external audits and inspection. To ensure QA records generated are archived on periodic basis. To assist Manager/ Department Head whenever required to collate quality systems data for trending the Quality metrics. To escalate immediately to Manager/ Department Head in case of any serious non-compliance to protocol and ALCOA+ principles. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role 1. Experience: 6 - 9 years 2. Demonstrated Capability: Auditing skills, Understanding of regulations & Attention to detail 3. Education: M.Sc., in Life Sciences or M. Pharm., 4. Sound technical Knowledge in ICH GCP, NDCT Rule and other applicable guidelines.

The Sr. Mgr will be responsible for study-level risk analysis and reporting and will be key contributor to the clinical study team to support the oversight of the sites/countries/studies for compliance, patient safety, data quality and reliability. The Sr. Mgr role has accountability to evaluate, monitor, escalate and report risks to the AD Risk Management and Central Monitoring that could potentially have a broad significant and/or systemic impact on quality, compliance, and operational deliverables for discussion with the relevant Governance Committee. The Sr. Mgr forms a key partnership with the AD Risk Management and Central Monitoring, R&D Quality (Risk Governance and Operations), applicable GDO & TA functions. Duties/Responsibilities Sr. Mgr to lead or contribute to Protocol De-risking process, support identification of critical to success factors, critical to quality factors - including critical data, critical processes Collaborate with the Data Management Lead (DML), Statistician, Global Trial Manager (GTM), Quality Lead, Clinical Trial Physician, Clinical Scientist and other study team members to put together an initial proposal on KRIs (standard and study specific) and Quality Tolerance Limits (QTLs). Proposal to include information on critical data, data source, data flow, data review frequency, external data transfer frequency etc. Responsible to lead and collaborate with the study team in the development of specifications to set up the KRIs, Data Quality Assessments (DQA) and QTLs. Partners with the DML and other data review functions to determine the holistic data review strategy for the study and determines the function-specific review objectives/analytics. Documents the Central Monitoring data analysis responsibilities in the Integrated Data Review Plan. Responsible for regular risk monitoring at study level for priority studies and providing a holistic risk report at the agreed frequency. Ensure appropriate escalations of emerging risks (including QTL deviations) to the AD Risk Management and Central Monitoring to be discussed at relevant governance bodies (e.g Quality Council/Therapeutic Area leadership) and proactively shares knowledge and insights across the CORM group. Triages new and previously open signals in preparation for the Risk Review Meetings (RRM) to prioritize the signals for discussion and prepare a list of recommended actions Lead or contribute to the Risk Review discussion to determine if newly opened signals reveal potential risks and require follow-up investigation and if previously opened signals can be closed or need further investigation / monitoring / action. Relates the insights from the CM analysis back to the original risk discussions to share a compelling risk story . Drives ongoing risk discussions within the study team throughout the lifecycle of the trial and ensures the Integrated Risk Management Plan (IRMP) is updated and remains current Contribute to the development and maintenance of metrics that inform the evaluation of risk monitoring performance and effectiveness. Leadership or participation in initiatives / continuous improvement opportunities within the CORM and broader organizations Supports the strategic direction of Risk Based Management within the business to include leadership of RBM innovation, education and embedding Ensure effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing Risk Management or Central Monitoring activities on behalf of BMS Coach, mentor and develop new team members. Takes on additional responsibilities as directed by leadership Reporting Relationship This role will report to an Associate Director, Risk Management and Central Monitoring within the CORM organization. Qualifications A minimum of a bachelor s degree in one of the following disciplines or related field: Life Sciences (preferred); Analytics; Data Science; Statistics; Business; is required. At least 5 years in the pharmaceutical industry with a sound understanding of drug development and 3 years of experience in clinical trial operations and/or Good Clinical Practice is required. Demonstrated expertise in Risk-Based Monitoring principles (Quality by Design, Risk Assessment & Control) and relevant tools (e.g RACT, risk analytics platforms, Veeva and other quality systems) Technical expert in data analysis and interpretation using data visualizations to derive meaningful insights; and an ability to effectively tell the story of the data findings Ability to contribute to the development and implementation of data visualizations and analyses to support Risk Management / Central Monitoring business needs. In depth understanding of GCP, compliance and regulatory expectations. Experience of audits and health authority inspections, root cause analysis and CAPA is preferred. Advanced Leadership skills with an ability to influence and manage key internal stakeholders including at the Senior Leadership Level Excellent communication, collaboration and teamwork skills with an ability to drive cross-functional stakeholders to consensus. An ability to create a compelling story based on data insights which is meaningful to the target audience.

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life This position has to handles new incoming and legacy Mobile Platform related Mobile Handsets, Tablets, Power dapters, Requirements, Test and Approvals. Responsibilities may include following and other duties may be assigned System Requirements Specifications Creation, Analysis, Documentation Investigate and resolve product / system issues, making improvements to address the issues. Product / System testing capabilities to evaluate product performance over varying use cases and use conditions Support leaders of system level to ensure proper and complete coverage along with confirming that the behavior of the system meets the requirements as well as user needs and intended uses Holding accountability for the product related requirements. Champion best practices and advanced testing techniques to obtain full test coverage with efficiency Review requirements for implantable medical device systems for testability and completeness that meet the expectations and uses of the customer, regulatory agencies, standards, etc. Ensure customer needs, use cases and user workflows are translated into specific, well-written requirements, design features and associated integration test cases. Participate in technical architecture activities for system definition, including partitioning, establishing performance measures, and well-defined interfaces to ensure high quality systems Perform/participate in Risk Analysis activities, such as FMEA, and Hazard Analysis activities for systems, features, and implementations with the intent to eliminate or mitigate the risks in the identified scenarios. Identify, investigate, and resolve product issues. Review technical literature and manuals Required Knowledge and Experience Bachelor s degree in Engineering discipline and 10+ years of technical engineering professional experience or Master s degree in Engineering discipline and 10+ years of technical engineering professional experience 6+ years Systems / Product development experience. Strong verbal/written communication and influence management skills. Ability to accomplish critical project level objectives in a team environment. Knowledge in System Engineering discipline or use of system engineering methodologies. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

Position- Deputy Manager- Solid-Dielectrics Employment Type- Fixed Term Employment on ERDA Rolls initially for 03 Years Location- Makarpura, Vadodara Qualification- Essential: M.Sc. (Organic or Inorganic Chemistry or Physics) (Full Time) Desirable: Ph.D. in Organic or Inorganic or Polymer chemistry or Physics Experience Description- ( Minimum 14 years to Maximum 18 years) Work experience in a testing laboratory or quality control department of industries in field of testing of solid electrical insulating materials involving mentioned work areas Role & responsibilities 1. To plan and monitor the day-to-day activities of solid insulating materials section 2. To achieve the revenue targets of section 3. To prepare capital & recurring expenditure budget for the section and take suitable actions/measures accordingly . 4. Purchase activities of lab. Including RFQ preparation, indent processing, technical evaluation 5. To motivate and guide the personnel of the section to carry-out R&D related to solid insulating materials. 6. Planning and implementation of quality system in the lab for all requirements of ISO/IEC : 17025-2017 7. To achieve annual revenue and capital budget decided by Management. 8. Prepare and monitor capital & revenue expenditure Improvement of productivity Skills required to perform above job effectively Technical: 1. Knowledge of organic & inorganic chemistry 2. Knowledge of oil testing & experience of solid insulating materials testing in an accredited lab 3. Experience of working in NABL accredited lab; Knowledge of quality system requirement as per ISO 17025 Behavioural: 1. Ability to take initiative, prioritize work, organize resources to achieve results and meet the deadlines set. 2. To interact positively with superiors, subordinates & team. 3. Ability of lead the team IT: 1. Basic knowledge of computers & MS office Knowledge of ERP software

Own, maintain, and continually improve the plant-wide Quality Management System (QMS) to guarantee that every toy leaving the line meets Indian BIS guidelines, international toy-safety standards, and customer expectations. Drive a zero-defect culture

Execute the customer service strategy for all products across the service network Ensure Key Service Deliveries like TAT,CSAT, CNPS, Productivity, Cost & Quality are met consistently Monitor the performance of service centers with strong periodic review mechanism Ensure data Accuracy / Sanctity in CRM Ensure adequate quality manpower in field Ensure no escalation from trade & end customers Ensure planned visits to trade & resolve issues timely & maintain good market reputation Keep Warranty consumption within norms with random audits Ensure to achieve revenue targets service center wise Ensure spare parts are managed effectively with no variance Manage MSL & credit limits across all service centers Ensure System & process are in place all across the network Monitor successful implementation of quality systems and standards in the service departments. Ensure all engineers are trained time to time with refresher & new hire trainings Develop available pool of Engineers for better productivity & drive

Job Title: Functional Analyst Location : Bangalore / Chennai Work closely with the Product Owner and Business Analyst in understanding the business goals and objectives and the requirements of the proposed solution. Help the Business Analyst in preparing the as-is and to-be business process maps to allow identification of requirements for the developing the new Ordering application. Analyze and decompose complex requirements; Perform gap analysis and write Functional Specifications based on an in-depth understanding of both business processes and local IT system functionalities. Assist the Business Analyst in documenting information gathered from multiple sources, highlight conflicting functional/non-functional requirements, and documenting the clarifications to enable the preparation of a clear and concise functional specification document. Convert the requirement discussions into functional requirement documents that follow the standard templates, well structured, and use natural language, and easy to understand. Drives the requirement management lifecycle, including the creation, grooming, development, and testing activities, overseeing the delivery of the product as per the requirements; Performs training to the users about processes and the systems involved in supporting such processes; Provides cross-functional support to other departments as required; Cooperate in system testing. Performs other duties as assigned; Provide assistance with troubleshooting / triaging of production issues to help with quicker resolution. REQUIRED PROFILE: Type and duration of previous experience: At least 8 to 12 years in an IT environment (implementation if possible) preferably in an industrial or process-driven environment and ideally in the laboratory industry. At least 5-7 years as a Business analyst/ Functional analyst / Product owner/Technical Writer in an IT environment. Good business understanding to facilitate discussions from top managers to end-users. Specific skills required: Technical knowledge: Strong and proven background in Information Technology. Experience as a Technical Writer/Business Analyst/Functional Analyst Experience in writing Functional Specification Documents Experience in creating Business process models, specifications, diagrams, and charts to provide direction to developers and/or the project team. Capacity to conceptualize creative solutions, document and sell solutions to all levels of the organization, including senior management; Ability to solve practical problems, define cause and effect, map dependencies in the process Organized, detail-oriented, analytical, curious, with demonstrated troubleshooting and investigation skills; Ability to prioritize tasks, multitask with organization and manage time effectively. Strong customer focus and ability to manage (internal or external) client expectations; Contribute to process mapping in a range of functional dependencies, including operations, purchasing, inventory, distribution, equipment, data management, quality systems and facilities Ability to work independently with limited oversight, in a complex global environment;