Employbridge
Job Description
We are looking for a
Senior Quality Engineer
to play a key role in maintaining and improving our ISO 13485 and AS9100 Quality Management Systems. This position will focus on driving compliance, resolving customer and supplier quality issues, and supporting continuous improvement initiatives in a precision machining/contract manufacturing environment. What You’ll Do Act as a subject matter expert for FDA 21 CFR 820, ISO 13485, and AS9100 requirements Lead and support CAPA, MRB, and root cause analysis activities to reduce non-conformances Investigate and resolve customer complaints and supplier quality concerns Support audits (internal, external, and supplier) and close out findings with corrective actions Provide inspection support (incoming, in-process, final) and ensure documentation accuracy Maintain calibration and validation of inspection equipment Monitor and report quality metrics, applying SPC and data analytics to identify trends Collaborate with cross-functional teams to drive Six Sigma and continuous improvement projects Support new product qualifications and customer quality expectations Requirements: Bachelor’s degree within Quality Assurance, Engineering, Business or equivalent 3+ years of progressive Quality Assurance experience in ISO 13485 and/or AS9100 environments 3+ years of experience in CNC machining or contract manufacturing U.S. Citizen or Permanent Resident is a requirement (ITAR facility) Preferred Skills: GD&T experience in a precision machining setting Hands-on ERP system experience Strong analytical and problem-solving skills with root cause methodology Proficiency in MS Office and Quality Management Systems Employbridge is an equal opportunity employer and welcomes applications from diverse candidates.
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We are looking for a
Senior Quality Engineer
to play a key role in maintaining and improving our ISO 13485 and AS9100 Quality Management Systems. This position will focus on driving compliance, resolving customer and supplier quality issues, and supporting continuous improvement initiatives in a precision machining/contract manufacturing environment. What You’ll Do Act as a subject matter expert for FDA 21 CFR 820, ISO 13485, and AS9100 requirements Lead and support CAPA, MRB, and root cause analysis activities to reduce non-conformances Investigate and resolve customer complaints and supplier quality concerns Support audits (internal, external, and supplier) and close out findings with corrective actions Provide inspection support (incoming, in-process, final) and ensure documentation accuracy Maintain calibration and validation of inspection equipment Monitor and report quality metrics, applying SPC and data analytics to identify trends Collaborate with cross-functional teams to drive Six Sigma and continuous improvement projects Support new product qualifications and customer quality expectations Requirements: Bachelor’s degree within Quality Assurance, Engineering, Business or equivalent 3+ years of progressive Quality Assurance experience in ISO 13485 and/or AS9100 environments 3+ years of experience in CNC machining or contract manufacturing U.S. Citizen or Permanent Resident is a requirement (ITAR facility) Preferred Skills: GD&T experience in a precision machining setting Hands-on ERP system experience Strong analytical and problem-solving skills with root cause methodology Proficiency in MS Office and Quality Management Systems Employbridge is an equal opportunity employer and welcomes applications from diverse candidates.
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