Boxborough, Massachusetts, United States of America, United States of America
Onsite
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.
Our Cranial & Spinal Technologies (CST) Operating Unit develops and delivers an integrated ecosystem of spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools for complex spine and cranial procedures. Platforms such as AiBLE™ connect these technologies to enhance surgical precision, streamline workflows, and support improved patient outcomes across the globe.
Check us out on LinkedIn: Medtronic CST
Job Description:
As a Supplier Quality Engineer II, you will play an integral role in ensuring the quality and reliability of supplier-provided materials, components, and services. You will lead supplier qualification activities, develop and execute risk-based audit plans, and assess supplier performance to ensure compliance with applicable quality and regulatory requirements while supporting continuous improvement initiatives.
Key Responsibilities:
Ensure suppliers consistently deliver high-quality parts, materials, and services that meet Medtronic requirements.
Qualify and approve suppliers in accordance with company standards and support supplier certification programs to drive quality and cost-effectiveness.
Monitor supplier performance from sourcing through manufacturing, proactively identifying, communicating, and resolving supplier-related quality issues.
Develop, prioritize, and execute supplier audit schedules to ensure compliance with Good Manufacturing Practices (GMP), quality standards, and regulatory requirements.
Assess suppliers’ quality systems, manufacturing processes, and operational performance, providing feedback and recommendations for continuous improvement.
Provide Supplier Quality Engineering support for New Product Development (NPD) projects, partnering with Component Engineering and Post-Market Supplier Quality teams to ensure robust supplier selection and qualification.
Drive quality planning and compliance activities throughout the NPD lifecycle, ensuring purchased materials and components meet applicable industry standards, regulatory requirements, and customer expectations.
Collaborate with Component Engineers to develop product acceptance sampling strategies, manage Approved Supplier List (ASL) activities, deploy Supplier-Owned Quality initiatives, and establish control plans for new products.
Define Receiving Inspection requirements and support validation of internal Medtronic test methods used to verify supplier-provided components and materials.
Implement strategies that prevent defects, improve supplier performance, and support the delivery of safe, reliable, and high-quality products to customers.
Location: Boxborough, MA
Onsite: At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. This role will require 15% of travel to enhance collaboration and ensure successful completion of projects.
Minimum requirement:
Bachelors degree in Engineering or Technical field with minimum of 2 years of relevant experience,
OR Advance degree in Engineering or Technical field with minimum of 0 years of relevant experience
Nice to Have (Preferred Qualifications):
Experience supporting supplier qualification, supplier audits, supplier development, and supplier performance management within a regulated industry.
Knowledge of quality management systems and applicable regulatory requirements, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and Good Manufacturing Practices (GMP).
Experience supporting New Product Development (NPD) activities, including Design Controls, risk management, process validation, and control plan development.
Proficiency in quality engineering tools and methodologies, including CAPA, root cause analysis, statistical techniques, FMEA, and continuous improvement practices.
Experience conducting supplier assessments and audits, with the ability to evaluate supplier quality systems and drive corrective actions.
ASQ certification (CQE, CSQP) and/or Lean Six Sigma Green Belt or Black Belt certification preferred.
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.
Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.
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.
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
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.
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