130 Iso 13485 Jobs - Page 6

Role & responsibilities BE/BTech/ME/M-Tech in Electrical & Electronics Engineering, with 7 to 9 years of experience New Product Introduction (NPI) and Product Life Cycle Management Candidate having expertise in Electrical/Electronics HW Circuit Design and development Candidate having expertise in Altium or CADENCE or Mentor Graphics Product Obsolescence Management/Sustenance and Value Engineering Understanding & on the job application of standards like ISO 14971, ISO 13485, IEC 60601-1 Understanding & exposure to regulatory aspects pertaining to FDA, MDR, NMPA, TGA, HC, MHLW Understanding & Exposure to D/P-FMEA, Design for Usability, Design for Manufacturing/Assembly, Design for Reliability Hands-on experience with tools like Track Wise, Clear-quest, Windchill, DOORs or equivalent

Job Position: PMS Service Medical Devices Complaints Handling Job Description: To handle medical device customer allegations in complaints management system . Candidate with knowledge on Medical devices usage, Complaint Evaluation, Investigation, Medical devices reporting including post-market surveillance (PMS) and CAPA. Roles and Responsibilities: To work on Complaint handling Process Evaluation, Regulatory Assessment, Investigation Work with lead in completing daily assignation. Organize and manage daily work allocation Complaints remediation using work instruction, compliance to process To drive efficiency and compliance. Collaborate with of cross function team (CFT) such as Intake, MDR, Investigation to execute the project and initiative. Daily status to lead associate Skills: 2 to 4 years of experience in Medical devices complaints handling or any PMS activities Working knowledge of appropriate global medical device regulations, requirements, and standards such as: CFR Parts 803, 806 and 820, ISO 13485, ISO 14971, EU Medical Device Directives/Regulations including MEDDEV Guidelines For Complaint Investigation Mechanical problem analysis skill needed An excellent communicator, both written and verbal Adopt to cross cultural differences Ability to work in a timeline driven environment Proficiency using tools such as Trackwise, Sales force, Service Max Educational Qualification: B.E./B.Tech (Bio-Medical, Mechanical), B.Pharm, BSc Bio Science Total working experience (TEX): 2 to 4 years Relevant experience (REX): 2+ years Interested Candidates reply me to this email ID : nagamathini.r@hcltech.com , with the below details with your updated resume. Applicable only for Hyderabad location - Hybrid model/ Short Joiners preferred. Candidate Name: Email: Phone: Exp.: Rev. Exp.: CTC: Exp. CTC: Current company: Notice Period: Location: Preferred Location: LWD: DOJ: Any Offers in hand currently:

Develop, implement, and maintain the QMS in alignment with ISO 13485:2016 standards. Create, review, and update QMS documentation, including quality policies, procedures, and work instructions. Support during External (Notified Body for ISO 13485:2016) and Corporate Audits and Provide real-time support to the auditors by delivering requested documents, records, and evidence. Maintain and update the Document Control System (Windchill) for controlled documents, including SOPs, work instructions, forms, and records. Ensure document revisions, approvals, and distribution align with company policies and regulatory requirements (ISO 13485, FDA, EUMDR, etc.). Coordinate with cross-functional teams to review and approve documentation. Maintain the periodic review the documents. Maintain and update the Learning Management System (SLMS) with training records. Track training completion rates and generate reports for management and audit purposes. Communicate training requirements to employees and provide reminders for upcoming deadlines. Assist in evaluating training effectiveness through feedback collection and performance metrics. Support internal and external audits by providing training records and evidence of compliance. Qualifications & experience: Education and Experience: BSC Biotechnology, B-Pharm / M-Pharm or related field from premier institutes 2-3 years of experience in Medical Device domain At least 1+ years of experience in training and Document controller. Skills: Strong analytical and problem-solving skills. Excellent written and verbal communication skills. Proficiency in QMS software and tools. Nice to Have : ISO 13485:2016 certification Soft Skills Excellent communication & interpersonal skills. High analytical skills. Able to run communicate effectively with senior leadership. Excellent problem-solving skills. Proactive to support both internal and external customers. Travel Percentage: None

Medical Writer / Technical Content Writer - Internship This internship is ideal for someone passionate about simplifying complex medical or technical information into clear, structured documents and engaging content. Required Skills: Draft and organise documents such as user manuals, work instructions, clinical evaluations, and regulatory submissions. Format documents according to internal templates and regulatory guidelines (e.g., ISO 13485, MDR, FDA, IVDR). Research and write blogs, articles, white papers, and social media content focused on regulatory trends, product safety, and medtech innovation. Contribute to internal knowledge bases and client training materials. Work with subject matter experts from R&D, Quality Assurance, and Regulatory Affairs teams to gather information. Gain exposure to technical writing tools, documentation control systems, and compliance workflows. Eligibility & Skills: Background in Life Sciences, Pharmacy, Biomedical Engineering, Biotechnology, or English. Strong writing and grammar skills, with an ability to explain scientific/technical concepts in simple terms. Interest in regulatory documentation and medical devices is a must. Basic proficiency in MS Office (Word, Excel, PowerPoint) or Google Docs. Prior writing samples (academic or creative) are preferred.

Manage high impact, complex sustaining & transfer projects that enables Philips to reduce risk, improve profitability, align with Philips strategic supply base and optimize supply chain flexibility. The primary function within this role is to execute engineering activities through the course of fast-paced, high quality transfer and sustaining projects. You will be responsible for driving meaningful and innovative product development, generating ideas/concepts in feature development to improve quality and reduce cost, as well as performing the role of a technical lead in taking the product development through manufacturing release while transferring products between suppliers and manage sustaining of different devices by following PDLM-MLD process. Your responsibilities: Design and detail components and systems, including conducting predictive analysis and calculations. Select materials and processes appropriate for those designs Obtain parts and create prototypes. Write test protocols, conduct tests, analyze data, and report results. Successfully interact with associates in other departments, such as Manufacturing Operations, Procurement, and engineering staff, to achieve project and product objectives. Develop new test methods and tools as necessary. Specify, acquire, and maintain lab equipment. Operate lab instruments such as micrometer, tachometer, manometers, flow meters, tensile and compression testers, data acquisition systems, environmental chambers, and computer programs. Be a highly motivated, self-disciplined, open-minded individual possessing hands-on skills. Requirements detailing, design specification preparation, implementation, test, and integration of Unit per the higher-level Requirement and - Design specifications/architectures. Ensures the mutual consistency and efficient integration of the separate modules in modular, easy-to-maintain units that meet the product specification. Understands and communicates the consequences of their design on the architecture. Determines the Unit interfaces (HW/SW) in close consultation with relevant disciplines. Ensures that there is proper documentation for his/her design. Keeps abreast of technical developments in own field through study of the literature and technical contacts and propagates it. Defines, execute, and take the lead in concept and feasibility studies with a limited scope to investigate the usability of new technologies. Contributes to technology roadmaps and other strategic-related activities. Takes technological or process-related improvements initiatives within the scope of at least the mechanical development group. Contributes to the Work Breakdown Structure/ the planning process of his/her area. Draws up personal schedule and reports on progress. Inspires team members to get the job done. Performs work in line with the processes that have been agreed in the department. You are a part of A high-impact, global organization within Philips that works across all modalities - The Supplier Transfer Excellence Team (STET). STET has been established as an entrepreneurial organization that focuses on fast-paced, high-quality portfolio transfers within the Philips global supply base to mitigate risk & maximize profitability. To succeed in this role, you should be having M.Tech / B. E/ B.Tech in Mechanical/ Automobile/ Industrial or Equivalent Engineering 10+ years of relevant experience in design & development of electro-mechanical sub-systems & systems. Strong communication and collaborative abilities proactively seeks out expertise and advice and input from others in a collaborative team-environment. In-depth knowledge and 8+ years of experience in the development of mechanical design Experience in creating design concepts and mechanical designs of complex parts or assemblies. Strong knowledge and experience in CAD/CAE. such Creo Experience in metal or plastic crafts (drilling, milling, etc.) would be appreciated Experience in PDM/ PLM (Windchill, Teamcenter etc) Good knowledge and experience with gate staged development governance, ideally familiar with ISO 13485 or FDA-regulated development processes. knowledge of medical requirements and regulatory standards is beneficial (such as IEC 60601-1) Capability to interact in cross-functional teams