Principal Quality Engineer (Wayne, NJ)
- Lead new product design development activities in the areas of Test Method Validation (TMV), design verification and validation, inspection plans/methods, and Equipment Installation Qualification.
- Drive resolution of design issues through active participation and leadership in cross-functional meetings.
- Create, review, and approve product design/process qualification/validation, design/process remediation, and change control documentation.
- Manage and coordinate technical validation activities, including protocol development, synchronization of interdepartmental activities, and evaluation/reporting of results.
- Lead and guide Quality Control activities including Equipment Installation Qualification, TMV, and software updates.
- Oversee and ensure effectiveness of Corrective and Preventive Actions (CAPA), including investigation quality, documentation completeness, timeliness, and closure effectiveness.
- Present and interpret Nonconformance and quality metrics during Monthly Metrics Reviews and Quarterly Management Reviews; represent the function during third-party audits; lead Health Hazard Evaluations and nonconformance dispositions.
- Plan and perform internal audits in collaboration with Quality Compliance.
- Provide leadership to manufacturing for resolution of quality-related issues in daily operations.
- Review and approve supplier-provided First Article Inspection (FAI) documentation.
- Lead or oversee investigations of equipment Out-of-Tolerance conditions and ensure robust root cause and corrective actions.
- Identify and drive implementation of continuous improvement opportunities across processes, production, QA testing, and systems.
- Communicate, influence, and align quality improvement efforts with Manufacturing, QA, R&D, and Engineering leadership.
- Mentor and train less experienced engineers, technicians, or interns to build organizational capability.
- Perform other related duties as assigned.
- Bachelor’s degree in Engineering, Science, or equivalent (required). Master’s in Engineering/Science (preferred).
- Minimum of 7 years of experience in quality assurance, quality engineering, or related functions in an FDA-regulated manufacturing environment (M.S. + 5 years acceptable).
- CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) certification (preferred).
- Subject Matter Expertise required in at least one of the following areas:
- CAPA systems & root cause methodologies (5 Whys, Fishbone, Shainin, Fault Tree, etc.)
- Risk management (ISO 14971, FMEA, Fault Tree Analysis)
- Test Method Validation & advanced statistical techniques (Gage R&R, ANOVA, DOE)
- Supplier Quality (SCARs, APQP, PPAP, incoming inspection standards)
- Design Controls (21 CFR 820.30, ISO 13485)
- Demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments.
- Strong knowledge of quality systems is required. Familiarity with analytical software applications is preferred.
- Project management and leadership experience is required. Previous experience supervising technicians and conducting and leading FDA/customer/corporate audits is preferred.
- Demonstrated ability to influence change and deliver measurable process improvements.
- Strong written and verbal communication skills with ability to effectively present to senior leadership.
- Proficiency in Microsoft Office suite and familiarity with quality/regulatory software tools (e.g., TrackWise, Windchill, SAP, Minitab).
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