Engineer II, Quality

Position Summary:

The Manufacturing Quality Engineer II is an independent Quality Engineer responsible for routine manufacturing quality assurance support for an assigned product line process family workcell or manufacturing area. The role owns routine NCMRs complaint manufacturing reviews CAPA support quality-health metrics and proactive defect-prevention activities.

Essential Duties & Responsibilities:

• Own routine NCMR investigations from initial evaluation through closure including containment affected-product impact assessment recurrence review technical rationale disposition recommendation and closure logic.

• Ensure NCMR records include clear problem statements objective evidence investigation summary product impact assessment disposition rationale execution evidence and timely record updates.

• Support CAPA initiation assessments and provide evidence-based recommendations when recurrence severity trends or systemic weaknesses warrant escalation.

• Lead or support routine root cause analysis using 5-Why fishbone Pareto stratification trend charts and related structured problem-solving tools.

• Own manufacturing review portions of internal and external complaints including production history NCMR/CAPA history inspection/test data potential escapes and product risk.

• Provide independent production quality support for line investigations rework/sort controls inspection method clarification process change review and manufacturing quality risk assessment.

• Support process validation equipment/fixture qualification manufacturing transfers acceptance criteria updates control plans and PFMEA maintenance as applicable.

• Present monthly area quality-health summaries covering top defects aging NCMRs complaint linkages CAPA signals and improvement actions.

• Lead small-to-medium defect-reduction documentation workflow inspection process-control or Kaizen improvement projects and maintain action logs charters sustainment plans and effectiveness checks.

• Coach QE I or Quality Specialist personnel on record completeness CI action tracking and task follow-up.

Knowledge Skills & Qualifications:

• Independent knowledge of NCMR ownership routine investigation leadership complaint manufacturing review CAPA support technical writing containment risk-based disposition and QMS record quality.

• Working knowledge of manufacturing-floor support basic validation/process-control support PFMEA/control plan linkage and audit-ready record expectations.

• Competency in Pareto analysis stratification trend charts basic SPC/capability 5-Why fishbone A3/PDCA Kaizen co-leadership and DMAIC basics.

• Strong communication cross-functional coordination stakeholder follow-up and ability to balance documentation execution with proactive defect prevention.

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; or equivalent combination of education and relevant experience.

• Typically 2-5 years of quality engineering manufacturing engineering supplier quality process engineering or regulated manufacturing experience.

• Experience with NCMRs CAPA support complaint investigation process control root cause analysis and manufacturing-floor support preferred.

• Yellow Belt expected or strongly preferred; Green Belt training/candidate status recommended. ASQ CQE or equivalent quality training is a plus.

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.