Operations Quality Engineer II
About The Position
The Operations Quality Engineer II supports the Operations Quality function within Advanced Surgical Instruments (ASI), specifically the Stapling product families, in a manufacturing environment focused on product quality, process performance, and compliance across production operations. The role partners with Engineering, Manufacturing, and cross-functional stakeholders to develop and maintain quality systems, resolve complex quality issues, and drive continuous improvement to support product reliability and operational excellence. Serving as a quality leader for manufacturing operations, engineering initiatives, and quality system improvements, this position drives product and process quality, leads complex investigations and improvement projects, and collaborates across functions to ensure compliance and operational excellence. The position is based in North Haven, Connecticut, requires onsite presence five days per week, and involves minimal travel.
Requirements
- Bachelor's degree with at least 2 years of quality, manufacturing, or engineering experience, or a Master's degree with no prior experience required.
- For a baccalaureate degree earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
Nice To Haves
- Experience in medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing environments, including supporting quality systems.
- Knowledge of Quality System Regulation (QSR), ISO 13485, or other applicable quality standards.
- Experience with process validation, test method validation, and/or equipment qualification activities.
- Experience conducting root cause investigations, implementing corrective and preventive actions (CAPA), and analyzing quality or process data using statistical and problem-solving tools.
- Experience supporting continuous improvement initiatives using Lean, Six Sigma, or similar methodologies; related certifications such as ASQ Certified Quality Engineer (CQE) or Six Sigma are preferred.
- Experience collaborating with cross-functional manufacturing, engineering, quality, and operations teams.
Responsibilities
- Support 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.
Benefits
- Competitive salary and flexible benefits package.
- Short-term incentive through the Medtronic Incentive Plan (MIP).
- Health insurance.
- Dental insurance.
- Vision insurance.
- Health Savings Account.
- Healthcare Flexible Spending Account.
- Life insurance.
- Long-term disability leave.
- Dependent daycare spending account.
- Tuition assistance or reimbursement.
- Simple Steps global well-being program.
- Incentive plans.
- 401(k) plan with 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
Mid Level
