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. The role helps ensure product quality, process performance, and compliance across production operations, working closely with Engineering, Manufacturing, and other stakeholders to maintain quality systems, resolve complex quality issues, and drive continuous improvement. The position is based in North Haven, Connecticut and requires onsite presence five days per week; minimal travel is expected. The role serves as a quality leader supporting manufacturing operations, engineering initiatives, and quality system improvements. It drives product and process quality, leads complex investigations and improvement projects, and partners cross-functionally to support compliance, operational excellence, and product reliability.
Requirements
- Bachelor's degree with 2+ years of quality, manufacturing, or engineering experience, or a master's degree with 0 years of quality, manufacturing, or engineering experience.
- Candidates for roles below Principal level must possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
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/process data using statistical and problem-solving tools.
- Experience supporting continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.
- ASQ Certified Quality Engineer (CQE), Six Sigma, or related certifications.
- Experience collaborating with cross-functional manufacturing, engineering, quality, and operations teams.
- For baccalaureate degrees earned outside the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
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.
- 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/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
- Medtronic Incentive Plan short-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
