Design Quality Assurance

Job Description

Key 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 (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.
• 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.

Job Description - Grade Specific

Qualification and Experience:

• Bachelors (or higher) degree in engineering with preference mechanical engineering.
• 5-9 years of experience in medical device quality engineering.
• Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation.
• Sound understanding of medical device regulatory requirements for Class II and III medical devices.
• Project planning – resourcing, timelines, quality and budgets.
• 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 training and experience
• Proficient in project management tools like MS project.
• Experience in GD&T
• Well versed with statistical analytical techniques and s/w tools like MATLAB, MINITAB.