QUALITY ENGINEER

Job Description:

• 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 (DOE's), FMEA sessions, Risk Management and ensure compliance to CTQ's and safety requirements.

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

Mandatory Skills:

Ensure adherence to the quality systems and design assurance SOPs.

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

• Provide statistical testing and reliability plans.

• Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.

• 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, and Software Validation Plan if applicable).

Tools:
Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis).

• Preference for candidates with CQE certification or similar trainin