Senior Quality Engineer
- Salary: 110K-125K
- Bonus: 6%
Objectives:
- Oversee Product Quality Engineering in the Medical Equipment department.
- Ensure compliance with federal, state, local, and international regulations and standards.
- Report quality system performance to site management.
- Manage product nonconformance (NCRs), support process changes, and new product launches.
- Own/support Corrective and Preventive Actions (CAPA).
Responsibilities:
- Drive CAPA activities using quality data analysis.
- Develop and maintain quality assurance procedures and work instructions.
- Monitor product quality through inspection, testing, and auditing.
- Maintain Device History Records per FDA requirements.
- Establish and report KPIs.
- Assist in product complaint evaluations and investigations.
- Lead quality improvement projects.
Requirements:
- Bachelor's in Engineering or Related Science.
- 3+ years in Quality Assurance with ISO 13485, FDA QSR, and Medical Device Directive.
- Experience with CAPA, nonconforming product management, and complaints investigation.
- Skilled in root cause analysis and problem-solving tools.
- Basic knowledge of Lean Manufacturing and Continuous Improvement.
Preferred Qualifications:
- Experience in electro-mechanical assembly manufacturing.
- FDA GMP training.
- Lean Six Sigma Green Belt Certification.
Benefits:
- Competitive salary and excellent benefits starting on hire date.
- 401K Plan with match and ongoing contribution.
- Paid time off: vacation, floating holidays, and sick time.
- Employee Stock Purchase Plan with match.
- Employee Incentive Bonus.
- Tuition Reimbursement.
- Ongoing performance feedback and annual compensation review.
thomas.hatfield@acepartners.co.uk
