Senior Quality Engineer

Key Responsibilities

• Lead the development, implementation, and maintenance of quality standards, processes, and protocols across manufacturing and product development activities.
• Partner closely with Manufacturing, Operations, R&D, and Process Engineering teams to ensure quality requirements are integrated into products and processes.
• Develop and execute inspection, testing, validation, and monitoring strategies to ensure compliance with quality and regulatory requirements.
• Design, specify, and evaluate inspection and testing methods, equipment, and measurement systems to support product quality and process performance.
• Analyze quality data, identify trends, and utilize statistical techniques to drive root cause investigations, risk mitigation, and continuous improvement initiatives.
• Lead investigations related to nonconforming materials, products, and processes, ensuring effective corrective and preventive actions are implemented.
• Support and drive CAPA, nonconformance, complaint, audit, and risk management activities.
• Ensure quality documentation, records, and processes comply with applicable regulatory requirements, quality system standards, and internal procedures.
• Collaborate on new product development, product transfers, process validations, and manufacturing improvements to ensure quality is built into every stage of the product lifecycle.
• Mentor and provide technical guidance to engineers and cross-functional teams on quality principles, tools, and best practices.
• Drive initiatives that improve product reliability, manufacturing efficiency, and overall quality system effectiveness.
• Required Qualifications: Must Have Bachelor’s Degree and Minimum of 4 years of relevant experience OR Advanced degree with a minimum of 2 years relevant experience Preferred Qualifications: Nice to Have Experience in medical device or other FDA regulated manufacturing environments.
• Strong understanding of quality systems, risk management, validation, CAPA, nonconformance management, and regulatory requirements.
• Experience supporting manufacturing operations and cross-functional engineering teams.
• Proficiency with statistical analysis, problem-solving methodologies, and continuous improvement tools.
• Knowledge of FDA Quality System Regulations, ISO 13485, and other applicable regulatory standards.
• Strong communication , collaboration, and project leadership skills.
• ASQ Certified Quality Engineer (CQE) or equivalent certification is a plus.
• 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.
• 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
• 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.
• Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.
• 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 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 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
• 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)
• Capital Accumulation Plan (available to Vice Presidents and above
• 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
• 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.