Senior Quality Engineer

Senior Quality Engineer

Requirements

• Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality

Responsibilities

• Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Preferred Qualifications

• Validation Experience (IQ, OQ, TMV, PQ)
• 5+ years of related quality engineering experience
• Previous Quality experience working in medical device or related industry
• Experience with FDA 21 CFR Part 820 FDA Quality System Regulation, MDSAP, ISO 14971 risk management and/or other relevant international standards.
• Certified Lean or Six Sigma Black Belt or experience in DMAIC methodology
• Experience with FTQ
• Working knowledge of hardware development for medical devices.