Senior Operations Quality Engineer - North Haven, CT

Medtronic; North Haven (CT); On-site; USD 98,000 - 148,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) plan with company match

Paid time off

Job summary

Medtronic in North Haven, CT is seeking a Senior Operations Quality Engineer to lead quality initiatives in Advanced Surgical Instruments. The role is based onsite five days a week with limited travel, partnering with engineering and manufacturing to ensure product quality and compliance.

The successful candidate will drive investigations, implement corrective actions, and support audits while mentoring team members and contributing to continuous improvement across operations.

Qualifications

• Bachelor's degree with 4+ years of quality, manufacturing, or engineering experience or a Master's with 2+ years in quality, manufacturing, or engineering; PhD also acceptable.
• Experience supporting quality systems within a regulated manufacturing environment.
• For degrees earned outside the United States, meet 8 C.F.R. § 214.2(h)(4)(iii)(A) requirements.

Responsibilities

• Lead quality engineering initiatives to improve product quality, manufacturing performance, and quality system effectiveness.
• Partner with manufacturing and engineering teams to establish 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 verify 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.

Education

Bachelor's degree in engineering or related field

Master's degree in engineering or related field

PhD in engineering or related field

Job description

We anticipate the application window for this opening will close on - 20 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

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.

Primary 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

• Salary ranges for U.S (excl. PR) locations (USD):$98,400.00 - $147,600.00
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
• The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program)
• The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Further details are available at the link below: Medtronic benefits and compensation plans

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.

In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.

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