Principal Operations Quality Engineer - North Haven, CT

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

Job summary

Medtronic in North Haven, CT, seeks a Principal Operations Quality Engineer to lead quality strategy across Stapling product families in a manufacturing setting. You will guide quality systems, interfaces with engineering and manufacturing, and ensure compliance with FDA ISO13485 and other standards.

The role requires a strong technical background, autonomy to drive improvements, and a track record of complex investigations and high-stakes decision making within a regulated environment.

Qualifications

• Bachelor's degree with 7+ years in quality/manufacturing or Master's with 5+ years.
• Experience in a regulated manufacturing environment.

Responsibilities

• Lead development and maintenance of quality standards and procedures for manufacturing operations.
• Partner with Engineering and Manufacturing to integrate quality requirements into products and controls.
• Develop inspection and testing methods to verify product performance and process capability.
• Design and oversee inspection/testing systems for quality assessment.
• Conduct root cause analyses and risk assessments to drive CAPA actions.
• Ensure documentation complies with internal procedures and regulatory standards.
• Lead quality improvement initiatives and guide cross-functional teams.
• Mentor quality professionals and participate in strategic projects.

Skills

Quality engineering

Root cause analysis

Statistical analysis

Regulatory compliance

Mentoring

Education

Bachelor's degree in engineering or related field

Master's degree in engineering or related field

PhD in a relevant field

Tools

CAPA systems

Change control systems

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.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life‑changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need. Life‑transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight‑driven care. Fresh viewpoints. Cutting‑edge AI, data, and automation. You’re shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [e-mail] To request removal of your personal information from our systems please email [e-mail]