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Position – Team Leader – Advanced Quality
Location – Gurgaon, Haryana
Who we want:
- Analytical problem solvers: People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- Dedicated achievers: Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Collaborative partners: People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
- Effective communicators: People who regularly share relevant status updates and effectively articulate issues and recommendations to stakeholders and senior management.
- Motivated product launchers: People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
What you will do:
- Lead and execute risk management activities for NPD projects/legacy care.
- Review quality assurance documentation to support mainly product developments and regulatory submissions.
- Support quality system maintenance and effectiveness by identifying and correcting deficiencies in procedures and practices.
- Lead Quality Engineering activities during product development to ensure the highest level of product and process quality. Provide guidance to R&D teams to ensure compliance with the company’s quality system and external standards.
- Engage in design reviews by identifying risks associated with the product used and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development cycle.
- Responsible for managing a high-performance team of individuals to create world-class medical devices.
- Review meetings with the team to monitor the progress of projects and provide guidance, develop contingent plans, and arrange resources as needed.
- Taking care of timely and quality deliverables for various projects.
- Work as a point of contact for all people-related aspects with the stakeholders and review meetings with the team to monitor the progress of projects and provide guidance, develop contingent plans, and arrange resources as needed.
- Develop an environment to focus on customer needs and an organization that has an advanced understanding of external and internal customers to effectively improve the design quality of products and services.
- Develop an open culture to instill confidence, diversity of perspectives, and knowledge sharing
- Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
- Review final design verification and validation reports.
- Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
- Evaluate predicate products for relevant quality issues that may impact new product development projects
What you need:
- Educational background of B.Tech/M.Tech in Mechanical Engineering / Biomedical / Computer Sciences
- Strong Work experience: 7-10 years out of which 5+ years’ experience in Design Quality Assurance (medical devices) or new product development (medical devices)
- ASQ Certified Quality Engineer or Certified Six Sigma Green Belt or Certified Quality Auditor preferred
- Excellent understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)
- Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.
- AQE should drive coordination with different departments (such as R&D, BML, Regulatory, Clinical) to ensure the resulting part/product/process is safe, compliant, and effective.
- Ability to read and interpret CAD drawings (Optional).
- Knowledge of ISO 14971, IEC 62366, Quality Concepts (e.g. CAPA, Audits, Statistics).
- Must possess strong project management skills as well as can manage multiple tasks simultaneously.
- Demonstrated ability to advocate for product excellence and quality.
- Strong experience in establishing world-class risk methodologies for complex systems based upon existing corporate/divisional approaches.
- Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews, and the other practices mentioned above.
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