Quality Engineer II, Manufacturing Operations
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
We are seeking a Quality Engineer II who is passionate about ensuring product quality and regulatory compliance in support of innovative medical devices. In this role, you’ll contribute to cross-functional efforts and continuous improvement in a dynamic, collaborative environment. In this role you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives.
This is an onsite role at the Danvers, MA location.
As a Quality Engineer II, you will:
Support product and process quality for Class II/III medical devices in a regulated manufacturing environment
Lead and support nonconformance investigations, CAPA (Corrective and Preventive Actions), and root cause analysis
Perform risk assessments and support risk management documentation (FMEA, fault tree analysis)
Provide quality engineering support for design changes, process improvements, and product launches
Review and approve validations, protocols, and test methods (IQ/OQ/PQ, MSA, etc.)
Analyze quality trends, monitor metrics, and recommend data-driven actions
Collaborate across functions (R&D, Manufacturing, Regulatory, and Supplier Quality) to ensure compliance and product integrity
Support audits and inspections (internal, supplier, and regulatory bodies)
Contribute to fostering a culture of inclusion, safety, and continuous learning
Must Have: Minimum Qualifications
Bachelor’s degree AND minimum of 2 years of relevant experience OR
Advanced degree with 0 years of experience
Nice to Have: Preferred Qualifications
2+ years of relevant quality, manufacturing, or product development experience in a regulated industry (medical device preferred)
Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and quality systems
Strong analytical, problem-solving, and effective communication skills
Strong interpersonal and influencing skills
Experience with CAPA, risk management tools, and statistical analysis
Lean, Six Sigma, or quality certifications (e.g., ASQ CQE)
Hands-on knowledge of root cause investigation and validation protocols
Experience working in an inclusive, cross-functional team setting
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.
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.
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
About Medtronic
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.
Learn more about our business, mission, and our commitment to diversity here.
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.
Average salary estimate
If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.
Advance cardiac care as a Principal Field Clinical Specialist supporting Mitral and Tricuspid Therapies clinical programs at Medtronic in Nashville.
Lead cardiology sales and drive revenue growth as Senior District Manager at Medtronic in Northern California.
Join Northrop Grumman as a Supplier Quality Engineer, specializing in PWB, and contribute to pioneering projects that shape the future.
Become a key player at Goldman Sachs as an Associate QA Engineer, driving innovation and quality across Wealth Management technology solutions.
As a Quality Assurance Associate at Thyme Care, you will play a key role in enhancing the quality of our enrollment processes in a mission-driven environment.
Join Medtronic as an Entry-Level Quality Engineer and play a crucial role in maintaining high standards of product quality in the healthcare sector.
Become an integral part of Eurofins Scientific as a Quality Assurance Specialist II, ensuring compliance and promoting quality in a dynamic life sciences environment.
We are looking for a driven QA/QC Manager for Process Piping to join WWPS, focusing on quality assurance in large-scale construction projects.
PNC is hiring a remote Quality Manager to lead and improve the CLLO Lookback team's quality management and operational risk efforts.
Exciting opportunity for a Semi-Senior QA Automation Analyst to lead test automation efforts for web applications using React and Python microservices.
Join Quantum Metric, a leader in Continuous Product Design, as a Senior iOS QA Engineer, ensuring top-notch quality for our iOS SDK.
Join Prime Healthcare as a Regional Quality Manager to enhance quality operations across our medical groups in the Missouri/Kansas market.
Become a vital part of AbbVie as a Data Integrity Lead, driving data governance and compliance across multiple departments.
2K Games is hiring a Data Analytics QA Tester to execute complex SQL queries and validate game telemetry data on-site in Las Vegas.
Become a key player in AbbVie's mission by managing external quality assurance for medical devices at our North Chicago facility.
Mission Written in 1960, our Mission dictates that our first and foremost priority is to contribute to human welfare. Over a half-century later, the Mission continues to serve as our ethical framework and inspirational goal for our employees aroun...
768 jobsSubscribe to Rise newsletter
🔮
Hi, I'm Risa! Your AI Career Copilot
you, just ask me below!
