Senior Operations Quality Engineer - North Haven, CT

Medtronic•North Haven, CT

3d•Onsite

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.
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.
Unrestricted U.S. work authorization at the time of hire and for the duration of employment (for roles below Principal level).

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.

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
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)