Quality Assurance Engineer
Core
Provide technical quality oversight across validation, equipment qualification, risk management, and continuous improvement activities to ensure compliance and safety in medical device manufacturing.
Role type
Quality Assurance Engineer (Medical Device)
Builds
Wound care products and regenerative healing solutions
Domain
Medical device manufacturing / Regenerative healing
Required skills
Quality Management Systems (QMS), cGMP, ISO 13485, 21 CFR Part 820, process validation, technical writing, root cause analysis
Preferred skills
Computer system/software validation
Responsibilities
Provide quality oversight and approval of validation activities and documentation; Engage with production floor processes and personnel to uphold quality standards; Collaborate with cross-functional teams to balance priorities and meet deadlines; Serve as a point of contact for QA technical issues and drive root cause analysis; Contribute to continuous improvement efforts for product quality and safety
