Engineer III, Quality-Manufacturing

Position Summary:

The Manufacturing Quality Engineer III is an advanced Quality Engineer and technical lead responsible for complex investigations CAPA quality manufacturing quality-health improvement risk-based process control and cross-functional problem solving. The role leads defect-reduction projects and mentors developing Quality Engineers.

Essential Duties & Responsibilities:

Lead complex NCMRs involving recurrence high cost multi-lot impact unclear root cause process-control weakness validation linkage supplier/manufacturing interface or potential customer/field impact.

Define investigation strategy required evidence containment rigor risk rationale disposition logic and escalation requirements for complex records.

Review and coach QE I/QE II NCMR complaint and CAPA records for technical quality GDP and closure readiness.

Support CAPA Owners with complex manufacturing quality issues by reviewing investigations root causes corrective actions supporting evidence and effectiveness checks.

Lead complex internal and external complaint manufacturing reviews including linkage to NCMR CAPA supplier process and field history.

Serve as technical quality lead for assigned manufacturing areas including process-control health validation support PFMEA/control plan linkage acceptance criteria inspection strategy and procedure/training improvements.

Occasionally support process changes for quality risk verification/validation needs inspection impacts supplier impacts and QMS record requirements.

Lead medium-to-large cross-functional continuous-improvement projects tied to NCMR reduction complaint reduction CAPA effectiveness process capability scrap/rework reduction or systemic process-control improvement.

Facilitate Kaizen events by defining scope pre-work metrics team roles current/future state root-cause logic implementation actions and sustainment plans.

Mentor QE I/QE II personnel on investigations CAPA thinking complaint reviews risk-based disposition data analysis CI methods and technical writing.

Knowledge Skills & Qualifications:

Advanced knowledge of complex investigation leadership CAPA root cause/action/effectiveness complaint technical conclusions process-control review validation/change support PFMEA/control plan linkage SPC/capability and risk management.

Green Belt-level DMAIC skill Kaizen facilitation A3/PDCA advanced root cause analysis project governance technical mentoring presentation skills and data-driven quality-health management.

Ability to influence Manufacturing Engineering Quality Systems Supplier Quality Operations and leadership toward sustainable quality improvements.

Strong audit readiness technical writing communication and cross-functional decision-making capability.

Education and Experience:

Must be at least 18 years of age.

Bachelors degree from an accredited college or university in Engineering Science Quality Technology or a related discipline; advanced degree or equivalent experience helpful.

At least 4-7 years relevant experience of quality engineering manufacturing quality process engineering supplier quality or regulated manufacturing experience.

Demonstrated experience leading complex NCMRs CAPAs complaint investigations process-control improvements and cross-functional problem solving.

Green Belt certification expected or strongly preferred. ASQ CQE lead auditor or equivalent quality certification preferred.

Physical Requirements and Work Environment:

This role requires both manufacturing and office environment.

While working in the manufacturing environment high-noise areas radiological hazards lasers and/or biological hazards may be encountered.

Lift up to 40 lbs unassisted.

Typically requires travel less than 5% of the time.