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Principal Supplier Quality Engineer - Jacksonville

Lead supplier qualification and quality assurance for new medical device products
Jacksonville, Florida, United States
Senior
$120,000 – 180,000 USD / year
yesterday
Medtronic Plc

Medtronic Plc

A global leader in medical technology, services, and solutions, specializing in medical devices for various therapeutic and diagnostic categories.

81 Similar Jobs at Medtronic Plc

Quality Engineer

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

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Responsibilities may include the following and other duties may be assigned:

  • Responsible for Pre-Market Supplier Quality, including providing Quality Engineering support to New Product Development (NPD) in partnership with R&D, Design Quality, Technical Sourcing, and Manufacturing Engineering teams. Focus areas include delivering high-quality parts, materials, and services, preventing defects, and ensuring Medtronic delivers reliable, high-performing products.
  • Drive the supplier selection process during the early phases of projects and assess quality impact levels.
  • Provide technical guidance and quality compliance throughout the NPD lifecycle for newly qualified parts. Implement strategies to drive product quality and continuous improvement, ensuring purchased products and components meet industry standards, regulatory requirements, and customer needs through the PPAP process.
  • Collaborate with R&D engineers to define and deliver Product Acceptance Sampling Strategies, coordinate the Approved Supplier List, deploy Supplier-Owned Quality, and establish Control Plans for new products.
  • Define receiving inspection requirements and oversee test method validation for all internal Medtronic test methods.
  • Ensure suppliers consistently deliver high-quality parts, materials, and services.
  • Qualify suppliers according to company standards using PPAP; may also administer the Certified Supplier Program within receiving inspection to support cost-effectiveness.
  • Monitor supplier performance from acquisition through manufacturing, addressing and resolving supplier-related issues as they arise.
  • Develop and prioritize an audit schedule to ensure designated suppliers are regularly assessed for compliance with Good Manufacturing Practices (GMP) and Medtronic's quality standards.
  • Evaluate suppliers' internal operations, assess overall performance, and provide structured feedback for continuous improvement.

Required Knowledge and Experience:

  • Requires a Baccalaureate degree
  • Minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience.

Nice to Have:

  • Experience leading transformative improvements and driving supplier strategy.
  • Experience working with Approved Supplier List (ASL) management, Nonconformance Material Review (NCMR), and creation of guidance documentation desired.
  • Experience performing Key Performance Indicator (KPI) analysis, PPAP, IQ, OQ, PQ, Measurement System Analysis (MSA), and Test Method Validations (TMVs).
  • Experience providing quality training and mentoring or developing junior SQEs and cross-functional partners in supplier quality engineering principles, PPAP, and risk management.
  • Experience with DFMEAs, PFMEAs, supplier risk files, and linking risk management through process control plans.
  • Experience implementing Design for Reliability and Manufacturability (DRM) at suppliers and supporting new product introductions desired.
  • Demonstrated ability to lead Lean initiatives and create standard work.
  • Demonstrated ability to conduct root cause analysis, deploy Supplier Owned Quality initiatives, and lead supplier CAPA closure through structured problem-solving tools such as A3, DMAIC, or 8D.
  • Knowledge of Lean Six Sigma tools, ISO 9001:2015, ISO 13485:2016, and statistical process control (SPC) required.
  • Experience with regulatory and post-market quality systems and understanding of FDA QSR and ISO 14971 principles.
  • Proficient in SAP, Agile PLM, Minitab, MS Office Suite, Power BI, and TrackWise.
  • Excellent communication skills required, with the ability to lead discussions with suppliers and executive leadership, and present data-driven recommendations effectively.

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.

Salary ranges for U.S (excl. PR) locations (USD):$120,000.00 - $180,000.00 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, 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 β€” to alleviate pain, restore health, and extend life β€” unites a global team of 95,000+ passionate people. We are engineers at heartβ€” 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 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

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Principal Supplier Quality Engineer - Jacksonville
Jacksonville, Florida, United States
$120,000 – 180,000 USD / year
Engineering
About Medtronic Plc
A global leader in medical technology, services, and solutions, specializing in medical devices for various therapeutic and diagnostic categories.