The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
Provide work direction for 1-3 Technicians/Inspectors.
Bachelor’s Degree in Engineering or related field required and 2-5+ years quality engineering experience, in medical device industry.
Strong CAPA experience. FMEAs, Control Plans, etc.
Cpk, DOE, Hypotheses Testing, etc.
Good knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.).
Proficient in Microsoft Office and Minitab.
Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six Sigma Green Belt or Black Belt desired.