[Hiring] Senior Supplier Quality Engineer @Medtronic

Role Description

The Supplier Quality function partners with Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), and critical suppliers to ensure the quality, compliance, and performance of externally manufactured products and components. This team works cross-functionally with Research & Development (R&D), Quality, Regulatory Affairs, and Operations to support product lifecycle activities, drive supplier performance improvements, and maintain compliance with applicable quality system and regulatory requirements.

This position may be performed remotely anywhere within the United States. Travel up to 15% is required to support supplier audits, supplier performance reviews, business meetings, and cross-functional initiatives.

The Senior Supplier Quality Engineer serves as the primary quality partner for strategic Contract Manufacturers and Original Equipment Manufacturers, ensuring supplier processes, products, and quality systems consistently meet Medtronic requirements. This role drives supplier quality performance, supports product and process changes, leads quality improvement initiatives, and provides technical quality guidance across supplier-related activities throughout the product lifecycle.

Primary Responsibilities

• Manage quality oversight of strategic Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), and designated suppliers to ensure compliance with product, process, and quality system requirements.
• Lead supplier quality activities associated with product and process changes, including risk assessment, qualification, validation, and implementation support.
• Monitor supplier performance metrics, identify quality risks and trends, and drive corrective and preventive actions to improve supplier effectiveness and product quality.
• Plan, conduct, and support supplier audits to assess compliance with Good Manufacturing Practices (GMP), quality standards, and regulatory requirements.
• Partner with Research & Development (R&D), Regulatory Affairs, Operations, and Quality teams to ensure supplied products and components meet finished device requirements.
• Investigate supplier-related nonconformances, complaints, and quality issues, facilitating root cause analysis and sustainable corrective actions.
• Provide Supplier Quality support for New Product Development (NPD) activities, including supplier qualification, product acceptance strategies, control plans, and supplier quality deliverables.
• Define and maintain receiving inspection requirements, supplier controls, and quality documentation necessary to support product acceptance and compliance.

Qualifications

• Bachelor’s Degree in Engineering, Science or technical field with 4 years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2 years of work experience in Engineering and/or Quality OR PhD with 0 years relevant experience.

Preferred Qualifications

• Experience working with supplier quality systems, supplier qualification, supplier audits, or supplier performance management.
• Experience supporting quality processes within a regulated industry environment.
• Experience interpreting and applying quality system requirements, technical documentation, specifications, and quality standards.
• Experience supporting Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), or external manufacturing partners within the medical device industry.
• Experience with New Product Development (NPD), product transfers, process validation, design transfer, or supplier onboarding activities.
• Lead Auditor or certified quality-related credential such as American Society for Quality (ASQ) certification.
• Knowledge of ISO 13485, 21 CFR Part 820, Good Manufacturing Practices (GMP), and global medical device regulatory requirements.
• Experience leading supplier corrective actions, continuous improvement initiatives, and cross-functional quality projects.
• 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

• 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): $99,200.00 - $148,800.00.
• 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.
• 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, 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.