Support product inception through commercial product
Lead a team of Quality Engineers supporting manufacturing processes and projects, providing quality oversight to the Engineering department within a multi-functional team environment for medical devices
Job Summary
Lead a team of Quality Engineers supporting manufacturing processes and projects, providing quality oversight to the Engineering department within a multi-functional team environment for medical devices.
Play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all applicable regulatory requirements.
Support continual improvement of products, processes or QMS and perform all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards.
Matching Summary
Lead a team of Quality Engineers supporting manufacturing processes and projects, providing quality oversight to the Engineering department within a multi-functional team environment for medical devices.
Skills & Requirements
Must-have
Quality oversight of manufacturing processes
Lead Quality Engineers
Support product inception through commercial product
Ensure products meet quality standards
Implement improvements within Quality Management System
Support continual improvement of products, processes or QMS
Auditing and documentation of compliance
GMP and ISO standards
Nice-to-have
Advocate for product, process, and system quality
Cross-functional collaboration
Strong quality first mentality
Lifelong learning and development opportunities
Key Requirements
B.Sc. in Engineering or Science
Minimum 5 years of experience in Medical Device / Pharma industry
Experience in Equipment Validation, Process Validation, Risk Management, Change Control Process
Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP