Senior Operations Quality Engineer - North Haven, CT
About The Position
This role supports the Operations Quality function within Advanced Surgical Instruments (ASI), specifically supporting the Stapling product families in a manufacturing environment focused on ensuring product quality, process performance, and compliance across production operations. The team partners closely with Engineering, Manufacturing, and cross-functional stakeholders to develop and maintain quality systems, resolve complex quality issues, and drive continuous improvement initiatives that support product reliability and operational excellence. This position is based in North Haven, Connecticut and requires onsite presence five (5) days per week. Minimal travel is expected. As a Senior Operations Quality Engineer, you will serve as a quality leader supporting manufacturing operations, engineering initiatives, and quality system improvements. This role is responsible for driving product and process quality, leading complex investigations and improvement projects, and partnering cross-functionally to ensure compliance, operational excellence, and product reliability.
Requirements
- Bachelor's degree with 4+ years of quality, manufacturing, or engineering experience OR Master's degree with 2+ years of quality, manufacturing, or engineering experience OR PhD.
- Experience supporting quality systems within a regulated manufacturing environment.
Nice To Haves
- Experience in medical device, pharmaceutical, biotechnology, or other highly regulated industries.
- Knowledge of Quality System Regulation (QSR), ISO 13485, or other applicable quality standards.
- Experience with process validation, test method validation, or equipment qualification activities.
- Experience leading continuous improvement projects using Lean, Six Sigma, or similar methodologies.
- ASQ Certified Quality Engineer (CQE), Six Sigma certification, or related quality certification.
- Experience conducting root cause investigations and implementing corrective and preventive actions.
- Experience analyzing quality or process data using statistical methods and problem-solving tools.
- Experience collaborating with cross-functional manufacturing, engineering, and operations teams.
- 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 quality engineering initiatives that improve product quality, manufacturing performance, and quality system effectiveness.
- Partner with manufacturing and engineering teams to establish, maintain, and enhance quality standards and control methods.
- Develop and implement inspection, testing, validation, and monitoring strategies for products and production processes.
- Analyze quality, process, and production data to identify trends, investigate issues, and drive corrective and preventive actions.
- Execute root cause investigations and ensure effective implementation and verification of corrective actions.
- Support regulatory, internal, and external audit readiness through compliant documentation and quality system execution.
- Influence cross-functional decisions by providing technical quality expertise and risk-based recommendations.
- Mentor quality team members and contribute to continuous improvement projects across operations.
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
