Quality Engineer II

XOM Medtronic Xomed, LLC; Mystic (CT); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

Health Savings Account

Healthcare Flexible Spending Account

Life Insurance

Long-term Disability

Paid Time Off

401(k) Plan

Job summary

Medtronic in Mystic, Connecticut, seeks a Quality Engineer II to support nonconformance investigations, CAPA activities, calibration management, and validation across a regulated medical device manufacturing environment. This role emphasizes cross-functional collaboration, documentation rigor, and continuous improvement within the quality system.

The position requires a Baccalaureate degree with 2+ years of relevant experience (or a Master\'s degree) and offers onsite, five-day-per-week work

Qualifications

• Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.
• Experience supporting quality system processes within a regulated manufacturing environment.
• Experience with nonconformance investigations, root cause analysis, and corrective action implementation.
• Working knowledge of quality documentation requirements and regulatory compliance standards.
• Ability to manage multiple projects and priorities while maintaining accurate and compliant documentation.

Responsibilities

• Support nonconformance investigations and partner with cross-functional teams to identify root causes and implement corrective actions.
• Facilitate Corrective and Preventive Action (CAPA) activities, including documentation, effectiveness verification, and closure.
• Maintain compliance of calibration programs and support calibration-related quality activities.
• Execute and support process and equipment validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and related validation documentation.
• Collaborate with manufacturing and engineering teams to establish, implement, and maintain product and process quality requirements.
• Develop, revise, and maintain quality documentation, procedures, and records to ensure compliance with quality system requirements.
• Analyze quality data and trends to identify improvement opportunities and support risk-based decision-making.
• Participate in internal audits, inspections, and regulatory readiness activities to ensure ongoing compliance.

Skills

CAPA investigations

Nonconformance investigations

Root cause analysis

Calibration

Process validation

Equipment validation

Regulatory compliance

Documentation

Quality system processes

SAP

TrackWise

Education

Bachelor's degree in a relevant field

Master's degree (preferred)

Tools

IQ/OQ/PQ

Job description

We anticipate the application window for this opening will close on - 25 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 The Mystic site is part of the Ear, Nose and Throat business and manufactures Merocel® sponge Class I medical devices used to support patient care. The Quality function partners with manufacturing, engineering, and operations teams to maintain compliance, support product quality, and drive continuous improvement across quality system processes. This position is based in Mystic, Connecticut and requires onsite support five days per week to effectively partner with cross-functional teams and support manufacturing operations. No travel is required for this role. As a Quality Engineer II, you will support quality system activities within a regulated medical device manufacturing environment, with a focus on nonconformance management, corrective and preventive action (CAPA), calibration, process and equipment validation, and compliance with applicable regulatory requirements. This role collaborates across functions to maintain quality system effectiveness, support manufacturing operations, and drive continuous improvement initiatives.

Primary Responsibilities

• Support nonconformance investigations and partner with cross-functional teams to identify root causes and implement corrective actions.
• Facilitate Corrective and Preventive Action (CAPA) activities, including documentation, effectiveness verification, and closure.
• Maintain compliance of calibration programs and support calibration-related quality activities.
• Execute and support process and equipment validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and related validation documentation.
• Collaborate with manufacturing and engineering teams to establish, implement, and maintain product and process quality requirements.
• Develop, revise, and maintain quality documentation, procedures, and records to ensure compliance with quality system requirements.
• Analyze quality data and trends to identify improvement opportunities and support risk-based decision-making.
• Participate in internal audits, inspections, and regulatory readiness activities to ensure ongoing compliance.

Required Qualifications

• Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.
• Experience supporting quality system processes within a regulated manufacturing environment.
• Experience with nonconformance investigations, root cause analysis, and corrective action implementation.
• Working knowledge of quality documentation requirements and regulatory compliance standards.
• Ability to manage multiple projects and priorities while maintaining accurate and compliant documentation.

Preferred Qualifications

• Experience within the medical device industry.
• Working knowledge of TrackWise quality management systems.
• Experience using SAP to support quality, manufacturing, or calibration activities.
• Knowledge of calibration management and process or equipment validation activities.
• Strong analytical skills with experience evaluating quality data and driving process improvements.
• 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. 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):$79,200.00 - $118,800.00 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 pertaining solely to candidates hired within the United States (local market compensation and benefits will apply for others).

• 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
• Simple Steps (global well-being program)

• 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)
• 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.