Senior Quality Engineer - Jacksonville, FL
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
This role supports Quality Engineering activities at the Jacksonville, Florida manufacturing site, with a primary focus on manufacturing operations and quality release processes that ensure materials and products meet established requirements before use in production and distribution. The position partners closely with Manufacturing, Operations, Supplier Quality, and Engineering teams to drive product quality, process effectiveness, and compliance across manufacturing operations.This is an onsite position based in Jacksonville, FL, requiring presence at the manufacturing facility five (5) days per week to support production operations. This role has the potential of up to 20% travel.
The Senior Quality Engineer leads quality engineering initiatives that support manufacturing operations, incoming inspection activities, and product release processes. This role is responsible for driving quality improvements, executing quality-focused projects, ensuring compliance with applicable requirements, and partnering cross-functionally to support manufacturing line performance and product quality objectives.
Primary Responsibilities:
- Lead quality operations, decision making on daily activities related to quality compliance, it is important to have good knowledge / experience with FDA, ISO 13485, ISO 14971, or other relevant regulatory standards.
- Analyze quality data and performance trends to identify opportunities for process improvement and risk reduction. Use of AI to create data analysis, PBI and Microsoft excel.
- Complaint Handling and manufacturing assessments.
- Lead projects focused on incoming inspection, material acceptance, and quality release processes to support manufacturing operations.
- Partner with Manufacturing, Operations, and Engineering teams to establish, implement, and maintain quality standards and inspection requirements.
- Develop, improve, and sustain quality procedures, controls, and protocols for materials, components, and finished products.
- Analyze quality data and performance trends to identify opportunities for process improvement and risk reduction.
- Design, implement, and evaluate inspection and testing methods to verify product and process conformity.
- Investigate nonconformances and quality issues, determine root cause, and implement corrective and preventive actions.
- Ensure quality documentation, records, and supporting evidence meet regulatory, compliance, and internal quality system requirements.
- Provide technical guidance on quality-related activities and support continuous improvement initiatives across manufacturing lines.
Required Qualifications:
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
- Bachelor's degree and 4+ years of quality engineering, manufacturing quality, or related experience OR Master's degree and 2+ years of quality engineering, manufacturing quality, or related experience OR PhD.
Preferred Qualifications:
- Experience in the medical device industry supporting manufacturing, quality, or regulatory functions.
- Working knowledge of FDA Quality System Regulation (QSR), ISO 13485, ISO 14971, Good Manufacturing Practices (GMP), and other applicable regulatory standards.
- Experience with audit planning, execution, management, complaint handling, and supplier or internal quality audits.
- Experience leading quality improvement, Continuous Improvement, Lean Manufacturing, Six Sigma, CAPA (Corrective and Preventive Action), nonconformance (NCMR), and root cause investigation activities.
- Proficiency in statistical analysis, process capability, and data-driven quality improvement tools, including Minitab, Microsoft Excel, and Power BI.
- Experience with incoming inspection, product release, quality control, and manufacturing quality systems.
- Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and electrical schematics.
- ASQ Certified Quality Engineer (CQE) or comparable quality certification.
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.
Recruitment Fraud Alert
We 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 [email protected].
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 - $147,600.00This 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, andSimple 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), andCapital 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.