309 Iso 13485 Jobs - Page 11

The Injection Molding Supervisor plays a critical role in overseeing and optimizing the production of high-quality injection-molded components, ensuring compliance with ISO 13485 (Medical Devices) and ISO 15378 (Primary Packaging for Medicinal Products) standards. This position is responsible for managing day-to-day operations, maintaining production efficiency, ensuring adherence to regulatory and quality requirements, and fostering a safe and productive work environment. : Diploma in Mechanical Engineering / Plastic Engineering / CIPET Must-Have Skills:

Role & responsibilities Responsible for documentation related to quality system guidelines. Responsible for maintaining the Company's internal audit program (including quality) and assess improvement initiatives resulting from all Audits internal and external. Monitor activities to ensure compliance with core quality measures. Responsible to close internal and externally identified non-conformities and review the implementation of CAPA plan Represent the management for all external Quality Audits as and when required/directed Conducting the internal audits on timely basis & follow for NCs closure Responsible to visit south warehouses as per management requirement/Customer requirement and rep...

System Engineer /Sr. Systems Engineer Location: Pune, India Company: InnoIQ Engineering (Subsidiary of B&W Engineering und Datensysteme GmbH, Germany) Industry: Medical Devices / Engineering Services Employment Type: Full-time Role Summary: We are seeking a meticulous and detail-oriented System Engineer to join our growing team. In this role, you will be responsible for translating product needs into clear, structured, and testable requirements and specifications that guide engineering teams through the development of medical devices. You will act as a critical bridge between product management, design, and engineering teams, ensuring that all stakeholder needs are accurately captured and do...

We are seeking a detail-oriented and proactive Supplier Quality Engineer (SQE) to ensure that our suppliers consistently deliver high-quality materials and components. The SQE will be responsible for evaluating supplier processes in Electromechanical commodities, conducting audits, managing non-conformances, and driving continuous improvement initiatives to meet company and customer quality standards. Key Responsibilities: Lead supplier approval development initiatives by assessing manufacturing/technology capabilities to improve quality, reduce costs, and enhance delivery performance. Work cross-functionally with engineering, procurement, and production teams to qualify new suppliers and ma...

We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team and play a key role in ensuring the regulatory compliance of our engineering services projects for leading global Healthcare/ MedTech clients. You will work closely with our engineering and quality teams, as well as clients regulatory team, to navigate the regulatory landscape and ensure a smooth and successful product launch. Roles Responsibilities : Collaborate with clients regulatory team to understand their specific regulatory requirements and strategies for its MedTech products. Provide regulatory guidance and support to our engineering and testing teams, ensuring that the system design, dev...

Role & responsibilities: • Be a part of core project team and support the quality engineering across the entire development cycle Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects. Lead the development and implementation of design verification and validation plans with project design lead. Lead the development of Critical to Quality (CTQs), design input and output documents. Lead the fixture qualification and test method validation. Participate and implement tools like Design of Experiments (DOEs), FMEA sessions, Risk Management and ensure compliance to CTQs and safety requirements. Manage electronic docu...

Job Summary: We are seeking a detail-oriented and proactive Supplier Quality Engineer (SQE) to ensure that our suppliers consistently deliver high-quality materials and components. The SQE will be responsible for evaluating supplier processes in Electromechanical commodities, conducting audits, managing non-conformances, and driving continuous improvement initiatives to meet company and customer quality standards. Key Responsibilities: Lead supplier approval & development initiatives by assessing manufacturing/technology capabilities to improve quality, reduce costs, and enhance delivery performance. Work cross-functionally with engineering, procurement, and production teams to qualify new s...

Role & responsibilities : Act as the lead internal auditor for medical device programs, ensuring compliance with ISO 13485 and U.S./EU regulations. Investigate non-conformances and implement effective corrective actions for medical device-related issues. Review onboarding checklists to ensure FDA and EU MDR requirements are met for all devices. Oversee compliance in shipping, labeling, and depot processes for investigational and commercial devices. Serve as the main contact during ISO 13485 audits and coordinate with logistics and external auditors. Monitor regulatory changes (FDA, EMA, MDR) and update quality systems accordingly. Administer the EDMS platform, managing system operations, use...

The Global Quality Data Management Analyst position is responsible for managing all data management tasks for the Quality and Regulatory Affairs organization in order to monitor the overall performance of the QMS related to product performance across the lifecycle of the device and to proactively determine actions plans as applicable. The primary responsibility is to perform trend analysis activities, data mining and reporting, as well as working on delivering various quality reports and assisting other groups such as Design Assurance, Quality Assurance, Engineering, Operations, New Product Development, Marketing and Business Units in management of end user customer experience and market act...

Why join AliveCor? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the worlds heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical EKG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, hundreds of thousands of users have taken more than 100-million heart health measurements and counting. The Opportunity: AliveCor seeks a Quality Sy...

The Role of the Associate Engineer (AE1/AE2) in Quality department is to prepare Work Instructions, line audit, FAR, FMEA, Control plan, Customer report preparation. To maintain and improve the Quality control stage and support the Organization to meet the required KPI s. Academic Qualification / Job Qualification: Diploma in EEE or ECE or E & I or Mech with more than 5 ~6years experience (or) BE in EEE or ECR or E&I or Mech with 4 - 5 years experience Skills / competence required to perform the Job : 1. Team player 2. Good knowledge in MS Office. 3. Good communication & interpersonal skills 4. Experience in EMS or OEM industry preferably Electronics Manufacturing industry 5. System Knowledg...

What you will do In this vital role You will play a key role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation. The initiative leverages state-of-the-art technologies, including Generative AI, Structured Content Management, and integrated data to automate the creation, review, and approval of regulatory content. Role Description: In this vital role as Senior Manager Information Systems, you will lead a dynamic team of technical product owners, business analysts, developers, test/validation engineers, project managers and scrum masters responsible for the ongoing ...

Role & responsibilities : ISO 9001/ISO 13485. Manage the Quality Management System. To provide QA support in all quality related matters and to ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements. Risk Management & CAPA. Establishing procedures and records as per requirement of standards and regulatory authorities. Responsible for establishing, managing, and implementing Records Management policy, Records. Retention and retrieval procedures are in place. To manage and execute internal and external audit schedules and follow up on action plan, Quality Auditing of External suppliers - maintain an annual auditing program. Regular Internal Quali...

A Day in the Life In this role, this role will partner with Quality System team members to generate, analyze, communicate, and follow up with stakeholders to actions related to standard reports for the following QMS processes: -Periodic Review of QMS procedures -Training coming due and/or overdue notifications -Quality Data Analysis (QDA) In addition, this role will assist in the retrieval, review, and archival of Allograft Tissue Tracing Records. Responsibilities may include the following and other duties may be assigned: Communicates and collaborates with internal stakeholders such as Quality, R&D, Regulatory, Operations, Service and Repair, Supplier Quality, Procurement, Operations Qualit...

Responsibilities: * Prepare documentation according to ISO 13485 standards. * Ensure compliance with EU MDR, US FDA & CDSCO guidelines. * Maintain regulatory documentation * Internal Audits

Experienced Candidates in QA as per ISO 13485 review batch records, handle deviations, CAPA, and audits; support validations; write and maintain SOPs; coordinate with cross-functional teams, documentation, and Compliance with regulatory standards. Required Candidate profile Graduate / Post Graduate in biotechnology / bio medical / Microbiology / Chemistry with strong hands on experience in QA operations in any Pharma or medical devices company.

Objectives of this role Design and develop hardware products, including circuit boards, components, and systems, while adhering to industry standards and best practices. Generate and maintain hardware design, testing, and quality control documentation. Participate in design reviews, risk assessments, and product validation activities to ensure compliance with regulations. Collaborate with cross-functional teams, including design, development and customer support, to provide feedback and input on product design, performance optimisation, and manufacturability. Your tasks Conduct thorough testing and validation of hardware products to ensure compliance with specifications, requirements and qua...

Work Flexibility: Hybrid What you will do: Coordinate with partners/end users to deliver value to business through opportunity identification, execution, and solution delivery. Ensure quality of process and product as defined in the appropriate operation and material specifications. Will select components and equipment based on analysis of specifications, reliability, and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols. May lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation. Will analyze equipment to establish operating data, conduct experimental test and re...

Why join AliveCor? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. Were on a mission to be the world s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical EKG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, hundreds of thousands of users have taken more than 100-million heart health measurements and counting. The Opportunity: AliveCor seeks a Quality Sy...

Career Category Quality Job Description Let s do this. Let s change the world. In this vital role you will act as the Quality Engineering representative on multi-functional teams, employ quality principles and company s procedures including but not limited to the areas of device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, to ensure development and lifecycle management of final product align with dynamic global regulations and standards. The Sr Quality Engineer will be an integral part of the design and development of combination products, providing quality oversight of the processes and deliverables generated throughout development and commercializ...

A Day in the Life SUMMARY OF POSITION The Software Engineer II V V will be responsible for analyzing the requirements, developing the test protocols for product verification and validation of complex electro-mechanical medical devices as per the regulatory standards ESSENTIAL DUTIES AND RESPONSIBILITIES Technology Support. Participate in Sprint planning. Familiarity and project scope and timelines. Understanding overall feature requirements, test automation framework and developing automation scripts Work closely with system and software Accountable for developing document artifacts as per QMS process. Make sure the testing protocol covers the requirements Traceability analysis to make sure ...

A Day in the Life SUMMARY OF POSITION The Software Engineer II V V will be responsible for analyzing the requirements, developing the test protocols for product verification and validation of complex electro-mechanical medical devices as per the regulatory standards ESSENTIAL DUTIES AND RESPONSIBILITIES Technology Support. Participate in Sprint planning. Familiarity and project scope and timelines. Understanding overall feature requirements, test automation framework and developing automation scripts Work closely with system and software Accountable for developing document artifacts as per QMS process. Make sure the testing protocol covers the requirements Traceability analysis to make sure ...

Role & responsibilities: Process Development &Optimization Define, document, and improve engineering workflows, protocols, and D&D procedures. Collaborate with cross-functional teams (Design, QA/RA, Manufacturing, Supply Chain) to standardize and streamline development processes. Support Design Control processes including Design Inputs/Outputs, Verification, and Validation activities. Technical Documentation Management Create, maintain, and control engineering documentation such as: Design History Files (DHF) Device Master Records (DMR) Engineering Change Orders (ECO) Risk Management Files (ISO 14971) Ensure traceability and version control using QMS tools. Assist in the preparation and form...

Role & responsibilities Manufacturing Drawing Preparation Create 2D manufacturing drawings and 3D models of mechanical components and assemblies. Generate: Part drawings with all required views, sections, and dimensions Assembly drawings with ballooning, BOM integration, and exploded views Fabrication drawings for sheet metal, welded structures, machined components, and plastic parts Apply appropriate Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5 or ISO standards. Define tolerances , surface finish , material specifications , welding symbols , and heat treatment notes . Incorporate machining allowances , fits , and limits for manufacturing feasibility. CAD & Drafting Tools Use...

We are seeking a PMS and Complaint Analyst with 4 to 6 years of expertise in ISO13485, ISO14971, ISO 62304 (Plus) MDR and EUMDR requirements will be a plus. Requirements: Experience in Complaint handling and PMS for Medical products. In-depth knowledge of Software product development lifecycle. Hands on with complaint management tools such as track wise Is plus. Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers and Manufacturing personnel to facilitate the complaint handling process globally Evaluate customer feedback, service records, and other sources of customer and internal for possible com...