Principal Operations Quality Engineer - North Haven, CT

Medtronic; North Haven (CT); On-site; USD 121,000 - 181,000; Full time

Benefits offered by this job

Health, dental & vision insurance

401(k) plan with employer matching

Tuition assistance

Job summary

Medtronic is seeking a Principal Operations Quality Engineer to lead quality strategies within Advanced Surgical Instruments. Based in North Haven, CT, you will drive quality systems, investigations, and CAPA across manufacturing operations.

You will mentor quality professionals, partner with Engineering and Manufacturing, and ensure compliance with FDA/ISO quality systems. This role requires strong technical autonomy and cross-functional influence.

Qualifications

• Bachelor's degree or higher with 7+ years of quality/manufacturing/engineering experience (or higher degrees with fewer years).
• Experience in a regulated manufacturing environment and quality engineering activities.

Responsibilities

• Lead quality standards development and maintenance for manufacturing operations and product quality.
• Partner with Engineering and Manufacturing to integrate quality requirements into products and processes.
• Develop inspection, testing, and evaluation methods to verify product performance and process capability.
• Design or oversee inspection and testing systems for product quality and manufacturing effectiveness.
• Conduct root cause investigations, statistical analyses, and risk assessments to drive corrective actions.
• Ensure quality documentation and processes comply with internal procedures and regulatory standards.
• Lead complex quality improvement initiatives and provide guidance on reliability and quality systems.

Skills

Quality engineering

Regulatory compliance

Statistical analysis

Root cause analysis

Cross-functional leadership

Education

Bachelor's degree in engineering or related field

Master's degree

PhD

Tools

CAPA system

Change control system

Process validation

Job description

We anticipate the application window for this opening will close on - 17 Sep 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 Principal Operations Quality Engineer, you will serve as a technical leader responsible for advancing quality strategies, supporting manufacturing and engineering operations, and driving improvements to products, processes, and quality systems. This role requires a high degree of technical expertise and autonomy to lead complex initiatives, influence cross-functional decision making, and ensure compliance with applicable quality standards and regulatory requirements.

Primary Responsibilities

• Lead the development, implementation, and maintenance of quality standards, procedures, and protocols supporting manufacturing operations and product quality.
• Partner with Engineering and Manufacturing teams to ensure quality requirements are effectively integrated into products, processes, and operational controls.
• Develop and implement inspection, testing, and evaluation methods to verify product performance, process capability, and equipment accuracy.
• Design, specify, or oversee inspection and testing systems used to assess product quality and manufacturing effectiveness.
• Conduct root cause investigations, statistical analyses, and risk assessments to identify quality issues and drive effective corrective and preventive actions.
• Ensure quality documentation, records, and processes remain compliant with internal procedures, regulatory requirements, and applicable standards.
• Lead complex quality improvement initiatives and provide technical guidance on product reliability, process controls, and quality system enhancements.
• Mentor and provide direction to quality professionals and cross-functional teams while serving as a key quality representative on strategic projects.

Required Qualifications

• Bachelor's degree and 7+ years of relevant quality, manufacturing, or engineering experience, OR Master's degree and 5+ years of relevant experience, OR PhD and 3+ years of relevant experience.
• Experience supporting quality engineering activities within a regulated manufacturing environment.

Preferred Qualifications

• Demonstrated subject matter expertise in manufacturing quality engineering, with the ability to independently assess complex product, process, and compliance issues and provide technically sound, audit-defensible decisions.
• Extensive experience leading complex, high-visibility investigations involving product nonconformances, manufacturing process failures, systemic quality issues, and potential regulatory or compliance risk.
• Proven ability to maintain sound technical judgment, prioritize risk, and make timely quality decisions in a fast-paced, high-pressure manufacturing environment.
• Strong hands-on manufacturing-floor experience evaluating product and process issues at the point of occurrence, gathering objective evidence, and determining appropriate containment, escalation, and disposition pathways.
• Advanced knowledge of FDA Quality System requirements, ISO 13485, risk management principles, CAPA, nonconforming product controls, change control, process validation, and other medical device quality-system processes.
• Demonstrated ability to apply root cause analysis, statistical methods, risk assessment, and engineering judgment to ambiguous or technically complex problems.
• Experience serving as the senior Quality Engineering representative during significant manufacturing events, cross-functional escalations, audits, or regulatory inspections.
• ASQ Certified Quality Engineer, Certified Quality Auditor, Six Sigma Black Belt, Shainen RedX, or similar professional certification.
• Experience mentoring engineers or leading technical project teams in a matrixed organization.

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.

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):$120,800.00 - $181,200.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

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).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

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.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.