Senior Quality Engineer

Medtronic plc; Boxborough (MA); Presencial; USD 98.000 - 148.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, Dental and Vision Insurance

401(k) with employer match

Paid time off

Descripción de la vacante

Medtronic CST in Boxborough, MA seeks a Senior Quality Engineer to lead quality activities across manufacturing operations, drive process improvements, and support regulatory compliance throughout the product lifecycle.

You will collaborate with cross-functional teams, investigate quality issues, and develop robust quality documentation and validation protocols in a fast-paced medical device environment onsite.

Formación

• Bachelor's degree or higher in a relevant field with 4+ years of experience in quality engineering or manufacturing.
• Experience applying quality tools for root cause analysis and process improvement.
• Experience working in a regulated environment with quality systems.
• Knowledge of process validation, risk management, and quality engineering methodologies.

Responsabilidades

• Lead quality engineering activities supporting manufacturing processes and product quality performance.
• Collaborate with Manufacturing, Operations, and R&D to implement process improvements and quality controls.
• Analyze quality data, identify trends, and drive corrective and preventive actions for nonconformances.
• Support root cause investigations and resolution of quality issues across product, process, and supplier quality.
• Develop, review, and approve quality documentation, validation protocols, and engineering changes.
• Ensure compliance with Quality Management System requirements and regulatory standards.
• Participate in risk assessments and drive continuous improvement initiatives.

Conocimientos

Quality engineering

Root cause analysis

Regulatory compliance

Quality data analysis

Process validation

Risk management

Educación

Bachelor's degree

Advanced degree

Descripción del empleo

We anticipate the application window for this opening will close on - 7 Nov 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

Cranial & Spinal Technologies (CST) develops therapies, technologies, and procedural solutions for the treatment of disorders and injuries affecting the spine and cranial anatomy.

The operating unit partners with healthcare providers worldwide to advance surgical outcomes through innovative implants, navigation, imaging, enabling technologies, and procedural excellence.

Check us out on LinkedIn: Medtronic CST

This position is based in Boxborough, Massachusetts, and supports onsite collaboration with cross-functional teams across Quality, Manufacturing, Operations, Research and Development, and Regulatory Affairs.

This is an onsite role with no travel required.

The Senior Quality Engineer serves as a quality representative supporting manufacturing operations, process improvements, product quality initiatives, and regulatory compliance activities. This role partners across functions to drive product quality, ensure process effectiveness, investigate quality issues, and support continuous improvement efforts throughout the product lifecycle.

Primary Responsibilities

• Lead quality engineering activities supporting manufacturing processes and product quality performance.
• Partner with Manufacturing, Operations, and Research and Development teams to implement process improvements and quality controls.
• Analyze quality data, identify trends, and drive corrective and preventive actions to address nonconformances.
• Support root cause investigations and resolution of product, process, and supplier quality issues.
• Develop, review, and approve quality documentation, procedures, validation protocols, and engineering changes.
• Ensure compliance with applicable Quality Management System requirements and regulatory standards.
• Participate in risk management activities and support product and process risk assessments.
• Drive continuous improvement initiatives that enhance product quality, process capability, and operational performance.

Required Qualifications

• Bachelor's degree and 4+ years of quality engineering, manufacturing, or regulated industry experience OR an advanced degree and 2+ years of quality engineering, manufacturing, or regulated industry experience.
• Experience applying quality tools for root cause analysis, corrective actions, and process improvement.
• Experience supporting quality systems within a regulated environment.
• Experience analyzing quality data and developing effective quality solutions.
• Working knowledge of process validation, risk management, or quality engineering methodologies.
• 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.

Preferred Qualifications

• Experience in medical device manufacturing.
• Knowledge of United States Food and Drug Administration regulations, ISO 13485, and Quality System requirements.
• Experience with nonconformance, corrective and preventive action, and change control processes.
• Experience supporting product transfers, process validations, or manufacturing process improvements.
• Certification as a Quality Engineer or related quality certification through the American Society for Quality.

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):$98,400.00 - $147,600.00

• 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).
• 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.

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.

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.

This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees.

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.