Associate Quality Manager
BD
- Mannford, OK
- Permanent
- Full-time
- Applying process controls such as process validation, equipment qualifications, component qualifications, test method validation, SPC, and Control Plans;
- Applying quality systems to the medical device industry;
- Conducting internal and external audits from internal and supplier’s sides;
- Overseeing quality systems including non-conforming materials, CAPA and processes improvement;
- US and International medical device industry standards including FDA Quality Systems Regulations, ISO 13485, MDD, EU MDR, Canadian MDR, Japan PMDA, ANVISA, and TGA;
- Applying Quality Engineering tools such as: Sampling Plans, Root Cause Analysis, or Statistics; and
- Creating risk management files including PFMEAs. Up to 20% domestic travel required.