Senior Quality Engineer - North Haven, CT
About The Position
The Surgical Sutures Manufacturing business within Surgical Innovations develops and manufactures critical medical device products used in surgical procedures worldwide. The Operations Quality team partners with manufacturing, engineering, and technical functions to ensure compliance, process capability, product quality, and continuous improvement across manufacturing operations. This position is based in North Haven, Connecticut and requires an onsite work schedule five (5) days per week at the manufacturing facility. Minimal travel is expected. As a Senior Quality Engineer, you will provide quality engineering support for manufacturing operations with a primary focus on process validation and quality system execution. This role partners closely with engineering and manufacturing teams to ensure compliant, effective, and sustainable manufacturing processes while driving product quality, process reliability, and regulatory compliance within a highly regulated medical device environment.
Requirements
- Bachelor's degree in Engineering, Science, or technical field with 4+ years of engineering and/or quality experience OR Master's degree in Engineering, Science, or technical field with 2+ years of engineering and/or quality experience OR PhD.
- 2+ years of experience executing process validation activities across the full validation lifecycle.
Nice To Haves
- Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or related engineering discipline; advanced degree preferred.
- Experience leading process validation activities for complex manufacturing processes in regulated environments.
- Experience with FDA-regulated medical device or pharmaceutical manufacturing.
- Experience using statistical analysis tools such as Minitab to support process improvement and quality decision making.
- Knowledge of Code of Federal Regulations (CFR) requirements, engineering drawings, machining, chemical processing, packaging, and sterilization processes.
- ASQ Certified Quality Engineer (CQE), Lean Six Sigma certification, or similar quality certification.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Lead process validation activities across the full validation lifecycle, including planning, protocol development, execution, analysis, reporting, and ongoing process monitoring.
- Partner with manufacturing and engineering teams to develop, implement, and maintain quality standards, controls, and manufacturing process requirements.
- Drive root cause investigations, corrective and preventive actions (CAPA), and nonconforming material (NCMR) activities to resolve quality issues and prevent recurrence.
- Analyze quality and process performance data using statistical methods to support risk-based decision making and continuous improvement initiatives.
- Develop and implement inspection, testing, and evaluation methods to verify product quality and manufacturing process capability.
- Support qualification and validation of manufacturing equipment, processes, and test methods.
- Ensure quality documentation, validation records, and manufacturing practices comply with applicable regulatory and quality system requirements.
- Mentor quality and engineering colleagues and provide technical leadership on complex quality and validation projects.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
