Job Description:

1. Design Quality Assurance

Key Responsibilities:

• Be a part of core project team and support the quality engineering across the entire development cycle

• Participate in product risk management, usability, reliability and design validation efforts for new product development and design change projects.

• Contribute to the development and implementation of design verification and validation plans with project design lead.

• Participate and implement tools like Design of Experiments (DOE’s), FMEA sessions, Risk Management and ensure compliance.

• Manage electronic document control and version control on all project related documents.

• Having experience on adherence to the quality systems and design assurance SOPs of clients.

• Exposure with usability, reliability, testing, verification and validation testing – internal and local vendors.

• statistical skills and technical writing skills

• Provide quality and compliance guidance as needed to product development or design change project teams to assure country specific compliance .

• Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan,).

• Co-Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and preferably Six Sigma problem solving methodologies).

• Devise and support the implementation of effective quality assurance, process controls, , and metrics that assure products meet or exceed quality.

Qualification and Experience:

• Bachelors (or higher) degree in engineering with preference of engineering background.

• 7-9+ years of experience in medical device quality engineering.

• Professional training certification in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation is preferred.

• Sound understanding of medical device regulatory requirements for Class II and III medical devices.

• Preference for candidates with CQE certification or similar training and experience

• Proficient in project management tools like MS project.

• Experience in GD&T

• having experience on statistical tool like, MINITAB.