Quality Engineer II

Medtronic plc; North Haven (CT); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

401(k) plan plus employer match

Employee Stock Purchase Plan

Job summary

Medtronic plc in North Haven, CT seeks a Quality Engineer II to support Surgical Sutures Manufacturing within the Surgical Innovations group. The role focuses on process validation, quality systems, CAPA, and collaboration with Engineering and Manufacturing to ensure compliant, high-quality products.

On-site five days a week, strong analytical skills and knowledge of IQ/OQ/TMV/PQ are required. The ideal candidate holds a Bachelor’s in Engineering/Science with 2+ years of quality experience; Six

Qualifications

• Bachelor’s degree in Engineering, Science, or a technical field required or advanced degree.
• 2+ years of Engineering/Quality experience preferred; US work authorization standard.
• Experience with process validation: IQ/OQ/TMV/PQ and CAPA activities.

Responsibilities

• Develop and maintain quality standards for manufacturing processes and products.
• Execute process validation activities across the validation lifecycle.
• Partner with Engineering and Manufacturing to maintain quality standards and resolve issues.
• Develop and implement inspection, testing, and evaluation methods for products and equipment.
• Perform QA testing and statistical analysis to evaluate process and product performance.
• Investigate nonconforming products and support CAPA activities.

Skills

Process validation

Quality systems

CAPA

Statistical analysis

Validation lifecycle

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Science, or a technical field

Advanced degree preferred

Tools

Minitab

Six Sigma

Job description

We anticipate the application window for this opening will close on - 12 Nov 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 LifeThe Quality Engineer II supports the Surgical Sutures Manufacturing business within Medtronic’s Surgical Innovations group and Enterprise Operations. The Quality Engineering function supports manufacturing operations through process validation, quality system execution, and maintenance of quality standards for medical device manufacturing.This role is 100% onsite at the North Haven, CT manufacturing site, five days per week.The Quality Engineer II provides quality engineering support for manufacturing operations, with a primary focus on process validation and quality system execution. This role partners with Engineering and Manufacturing to maintain product and process quality, execute validation activities, address nonconformances, and ensure required quality documentation is complete and compliant.Primary ResponsibilitiesDevelop, apply, and maintain quality standards and protocols for manufacturing processes and products.Execute process validation activities across the validation lifecycle, supporting compliant and reliable manufacturing processes.Partner with Engineering and Manufacturing to establish and maintain quality standards and resolve product and process quality issues.Develop and implement inspection, testing, and evaluation methods for products, materials, processes, and production equipment.Perform quality assurance testing and statistical analysis to evaluate process and product performance.Investigate nonconforming products or materials and support corrective and preventive action (CAPA) activities.Ensure corrective measures meet reliability standards and associated quality documentation complies with requirements.Support quality activities across production control, product evaluation, reliability, incoming materials, and process quality.Required QualificationsBachelor’s degree in Engineering, Science, or a technical field with 2+ years of Engineering and/or Quality experience OR advanced degree in Engineering, Science, or a technical field with 0 years of Engineering and/or Quality experiencePreferred QualificationsBachelor’s degree in Chemical, Biomedical, or Mechanical Engineering; advanced degree preferred.Manufacturing environment experience.Process validation experience across the validation lifecycle, including Installation Qualification (IQ), Operational Qualification (OQ), Test Method Validation (TMV), and Performance Qualification (PQ).Corrective and Preventive Action (CAPA) experience.Experience with Minitab statistical software and/or Six Sigma training.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 RequirementsThe 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 & SponsorshipAt 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 AlertWe 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 & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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):$79,200.00 - $118,800.00This 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.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.