Job Description: We are seeking an experienced Lead Quality Engineer to provide technical leadership for quality engineering activities within a regulated manufacturing environment. The role will lead quality improvement initiatives, validation activities, risk management, CAPA, nonconformance investigations, supplier quality, and new product development while ensuring compliance with applicable FDA, ISO, GMP, and quality system requirements.
Responsibilities: - Lead and provide technical direction for Quality Engineering activities across manufacturing and product development.
- Develop, implement, and maintain quality plans, procedures, and engineering controls.
- Lead CAPA, nonconformance, deviation, complaint, and root cause investigations.
- Support and lead process validation, equipment qualification, and test method validation activities.
- Develop and review PFMEA, DFMEA, risk assessments, control plans, and inspection plans.
- Support Design Controls, Verification & Validation (V&V), NPI, and Design Transfer activities.
- Lead continuous improvement initiatives using Lean, Six Sigma, SPC, DOE, and statistical analysis.
- Monitor process capability, quality metrics, defects, and trends to identify improvement opportunities.
- Provide quality engineering support for manufacturing process development and sustaining engineering.
- Lead supplier quality activities, including supplier qualification, audits, corrective actions, and performance improvement.
- Ensure compliance with FDA regulations, ISO 13485, GMP, and applicable quality standards.
- Support internal, supplier, and regulatory audits.
- Review and approve quality and validation documentation.
- Collaborate with R&D, Manufacturing, Operations, Regulatory, Supply Chain, and Supplier Quality teams.
- Provide technical guidance, mentoring, and training to junior Quality Engineers.
- Lead moderately to highly complex quality projects and ensure delivery within established timelines.
Requirements: - Bachelor's degree in engineering, Quality, Manufacturing, Mechanical, Biomedical, Industrial Engineering, or related field.
- 7+ years of Quality Engineering experience, preferably in medical device, pharmaceutical, biotech, or other regulated manufacturing environments.
- Strong knowledge of Quality Management Systems and regulatory requirements.
- Experience with CAPA, nonconformance, root cause analysis, risk management, and process validation.
- Hands-on experience with PFMEA/DFMEA, SPC, MSA, Gage R&R, and Control Plans.
- Strong analytical, problem-solving, project management, and communication skills.
- Experience leading cross-functional teams and quality improvement projects.
Preferred Qualifications: - SQ Certified Quality Engineer (CQE) certification.
- Lean Six Sigma Green Belt or Black Belt certification.
- Experience with FDA 21 CFR Part 820 and ISO 13485.
- Experience with Minitab, JMP, or other statistical software.
- Experience with Design Controls and medical device product development.
- Experience with supplier quality and manufacturing transfers.
- Master's degree in Engineering or Quality-related discipline preferred.
