Senior Quality Engineer - North Haven, CT

Medtronic; North Haven, Northern (CT, KY); Hybrid; USD 98,000 - 148,000; Full time

Benefits offered by this job

Health, Dental and Vision insurance

401(k) plan with employer match

Tuition assistance

Job summary

Medtronic plc in North Haven, CT is seeking a Senior Quality Engineer to lead process validation and quality system execution in a regulated medical device environment. You will collaborate with manufacturing and engineering to uphold quality standards and drive continuous improvement, while mentoring staff.

The role emphasizes validation lifecycle leadership, analysis of quality data with Minitab, and CAPA/NCMR activities to ensure compliant, reliable manufacturing processes.

Qualifications

• Bachelor's degree in Engineering, Science, or technical field with 4+ years of engineering and/or quality experience or Master's with 2+ years.
• Experience executing process validation across full lifecycle.
• Knowledge of CFR requirements and GMP in regulated environments.

Responsibilities

• Lead process validation activities across the full validation lifecycle (planning, protocol, execution, analysis, reporting).
• Partner with manufacturing and engineering to implement quality standards and process requirements.
• Drive CAPA and NCMR activities to resolve quality issues and prevent recurrence.
• Analyze quality and process data using statistical methods for risk-based decisions.
• Develop inspection, testing, and evaluation methods to verify product quality.
• Support qualification/validation of equipment, processes, and test methods.
• Ensure documentation and manufacturing practices comply with regulations.
• Mentor quality and engineering colleagues on complex projects.

Skills

Process validation

CAPA

Statistical analysis

Quality systems

Risk analysis

Minitab

FDA-regulated environment

Education

Bachelor's degree in Engineering/Science

Master's degree in Engineering/Science

PhD in a technical field

Tools

Minitab

Job description

## Senior Quality Engineer - North Haven, CTApply: Onsite: North Haven, Connecticut, United States of America: Full time: Posted Today: End Date: October 19, 2026 (10 days left to apply): R79252We anticipate the application window for this opening will close on - 19 Oct 2026Careers 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**The Surgical Sutures Manufacturing business within Surgical Innovations develops and manufactures critical medical device products used in surgical procedures worldwide. The Operations Quality team partners with manufacturing, engineering, and technical functions to ensure compliance, process capability, product quality, and continuous improvement across manufacturing operations. This position is based in North Haven, Connecticut and requires an onsite work schedule five (5) days per week at the manufacturing facility. Minimal travel is expected. As a Senior Quality Engineer, you will provide quality engineering support for manufacturing operations with a primary focus on process validation and quality system execution. This role partners closely with engineering and manufacturing teams to ensure compliant, effective, and sustainable manufacturing processes while driving product quality, process reliability, and regulatory compliance within a highly regulated medical device environment. **Primary Responsibilities*** Lead process validation activities across the full validation lifecycle, including planning, protocol development, execution, analysis, reporting, and ongoing process monitoring.* Partner with manufacturing and engineering teams to develop, implement, and maintain quality standards, controls, and manufacturing process requirements.* Drive root cause investigations, corrective and preventive actions (CAPA), and nonconforming material (NCMR) activities to resolve quality issues and prevent recurrence.* Analyze quality and process performance data using statistical methods to support risk-based decision making and continuous improvement initiatives.* Develop and implement inspection, testing, and evaluation methods to verify product quality and manufacturing process capability.* Support qualification and validation of manufacturing equipment, processes, and test methods.* Ensure quality documentation, validation records, and manufacturing practices comply with applicable regulatory and quality system requirements.* Mentor quality and engineering colleagues and provide technical leadership on complex quality and validation projects. **Required Qualifications*** Bachelor's degree in Engineering, Science, or technical field with 4+ years of engineering and/or quality experience OR Master's degree in Engineering, Science, or technical field with 2+ years of engineering and/or quality experience OR PhD.* 2+ years of experience executing process validation activities across the full validation lifecycle. **Preferred Qualifications*** Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or related engineering discipline; advanced degree preferred.* Experience leading process validation activities for complex manufacturing processes in regulated environments.* Experience with FDA-regulated medical device or pharmaceutical manufacturing.* Experience using statistical analysis tools such as Minitab to support process improvement and quality decision making.* Knowledge of Code of Federal Regulations (CFR) requirements, engineering drawings, machining, chemical processing, packaging, and sterilization processes.* ASQ Certified Quality Engineer (CQE), Lean Six Sigma certification, or similar quality certification. 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.**Recruitment Fraud Alert**We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [e-mail].# **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 - $147,600.00This 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 plansIt 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.