A local client is currently looking to hire a Senior Quality Engineer to join their well-established organization. They offer competitive compensation up to $110,000, stock options, medical benefits, vacation, PTO and much more!
The Quality Engineer will support Manufacturing, Supply Chain, and Customer Facing functions on applicable product quality, design control, and risk management processes.
Experience in Biotech instrument development and commercialization activities. Experience with product risk analysis and management throughout product lifecycle. Experience with injection molding and assembly preferred. Familiar with reliability analysis and test methods and test method validation. Familiar with process validation principles, including sub-tasks of equipment IQ, OQ, PQ. Working knowledge of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, and ISO 14971 Risk Management Standard. tools for managing quality performance • CQE preferred Education • 4+ years’ experience working in the Medical Device and/or Life Science Research product industries. Experience interacting with regulatory agencies and notified bodies and front room audit experience is a plus. Knowledge and experience with corrective action and preventive action system, release test statistical sampling methods, quality risk management, FMEA, and DOE.
For immediate consideration, apply today!
We are an Equal Employment Opportunity employer committed to excellence, diversity and inclusion.
Job ID: 4203609917774995401