Senior Quality Engineer, Combo Product External Quality
AbbVie
2 months ago
Remote friendly (Tempe, AZ)
United States
Operations
Senior Quality Engineer – Combination Products External Quality
Responsibilities
- Support supplier quality development projects and continuous improvement activities.
- Investigate/coordinate resolution of supplier quality issues, including disposition of non-conforming product, events, deviations, and market complaints.
- Initiate and follow up on Supplier Corrective Action Requests (SCARs).
- Validate supplier corrective actions involving design and/or process changes to ensure they are robust, sustainable, and address similar concerns across manufacturing lines/suppliers.
- Coordinate supplier change notifications; assess impacts and open change plans to mitigate any impact to AbbVie product/processes.
- Develop receiving inspection test methods, sampling plans, and acceptance criteria for new/existing components and materials (including first article inspection) with Product Development and Manufacturing/Process Engineers.
- Review and monitor strategic supplier performance, including trend analysis, investigations, and CAPA for monthly quality review.
- Liaise with internal customers for effective problem resolution; develop metrics and reports; identify supplier non-conformance trends.
- Develop and implement product quality plans, specifications, quality plans, risk analyses, and FMEAs.
- Assist in maintaining a quality system aligned to ISO 13485, CFR 820 QSMR, EU MDR, and ISO 14971.
- Assist with internal Regulatory or Notified Body audits.
- Perform continuous improvement to enhance product quality, compliance, and the quality system.
- Establish/maintain relationships and quality agreements with suppliers/contract manufacturers.
- Plan, execute, and deliver projects within time/cost parameters.
- Support supplier qualification activities as needed.
Qualifications
- Bachelor’s degree, preferably in Biology, Chemistry, or Engineering.
- 6+ years’ experience in Manufacturing, Quality, or Engineering.
- Good verbal and written communication skills.
- Strong problem-solving and analytical skills.
- Strong interpersonal/communications skills.
- Good negotiation skills.
- Knowledge of quality/compliance management and regulations/standards affecting API, Bulk Drug, or Finished goods manufacturing.
Benefits
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible to participate in short-term incentive programs.
Responsibilities
- Support supplier quality development projects and continuous improvement activities.
- Investigate/coordinate resolution of supplier quality issues, including disposition of non-conforming product, events, deviations, and market complaints.
- Initiate and follow up on Supplier Corrective Action Requests (SCARs).
- Validate supplier corrective actions involving design and/or process changes to ensure they are robust, sustainable, and address similar concerns across manufacturing lines/suppliers.
- Coordinate supplier change notifications; assess impacts and open change plans to mitigate any impact to AbbVie product/processes.
- Develop receiving inspection test methods, sampling plans, and acceptance criteria for new/existing components and materials (including first article inspection) with Product Development and Manufacturing/Process Engineers.
- Review and monitor strategic supplier performance, including trend analysis, investigations, and CAPA for monthly quality review.
- Liaise with internal customers for effective problem resolution; develop metrics and reports; identify supplier non-conformance trends.
- Develop and implement product quality plans, specifications, quality plans, risk analyses, and FMEAs.
- Assist in maintaining a quality system aligned to ISO 13485, CFR 820 QSMR, EU MDR, and ISO 14971.
- Assist with internal Regulatory or Notified Body audits.
- Perform continuous improvement to enhance product quality, compliance, and the quality system.
- Establish/maintain relationships and quality agreements with suppliers/contract manufacturers.
- Plan, execute, and deliver projects within time/cost parameters.
- Support supplier qualification activities as needed.
Qualifications
- Bachelor’s degree, preferably in Biology, Chemistry, or Engineering.
- 6+ years’ experience in Manufacturing, Quality, or Engineering.
- Good verbal and written communication skills.
- Strong problem-solving and analytical skills.
- Strong interpersonal/communications skills.
- Good negotiation skills.
- Knowledge of quality/compliance management and regulations/standards affecting API, Bulk Drug, or Finished goods manufacturing.
Benefits
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible to participate in short-term incentive programs.