Supplier Quality Engineer II

Medtronic•Memphis, TN

17h•$80,000 - $120,000•Onsite

About The Position

At Medtronic, we put patients first in everything we do. We are seeking a committed professional to join our team as a Supplier Quality Engineer II, supporting Pre-Market Supplier Quality Engineering activities for the Cranial & Spinal Technologies (CST) Operating Unit. The Supplier Quality team primarily supports NPI (New Product Introduction) projects and supplier management activities and processes. The scope of this position will primarily focus on Spine and biologics hardware and procedures but may have responsibilities for other portions of CST. We are working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. Medtronic is a global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life. Our mission unites a global team of passionate people who are engineers at heart, putting ambitious ideas to work to generate real solutions for real people. We foster an inclusive culture where diverse perspectives inspire bold answers to challenges and where everyone can thrive.

Requirements

Bachelor's degree in Engineering required.
Minimum of 2 years of relevant experience, or advanced degree with 0 years of relevant experience.
Experience or coursework in supplier quality, manufacturing quality, or a related engineering discipline.
Familiarity with ISO 13485 or FDA 21 CFR 820 quality management systems.
Strong organizational, technical writing, and communication skills.
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.
Unrestricted U.S. work authorization at the time of hire and for the duration of employment (for roles below Principal level).

Nice To Haves

Knowledge of DRM, Lean, and Six Sigma principles.
Knowledge of GD&T.
Familiarity with Risk Management tools such as DFMEA or PFMEA.
Exposure to validation activities (IQ, OQ, PQ).
Knowledge of manufacturing assembly processes and inspection and testing methods.
Familiarity with NPI processes.

Responsibilities

Supports Pre-Market Supplier Quality Engineering activities for New Product Introduction (NPI) projects, working in partnership with project teams and Post-Market Supplier Quality Teams to help deliver quality parts, materials, and services that allow Medtronic to provide customers with the highest quality and reliable products.
Assists in driving supplier requirements by collaborating with Product Development Engineering and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk.
Works with suppliers to ensure parts are designed for reliability, manufacturability, and cost.
Supports supplier qualification activities according to company standards including supplier segmentation, early supplier involvement, supplier selection, approved supplier list requirements, and supplier agreements.
May participate in supplier audits (QMS and process audits) to ensure good manufacturing practices and quality standards are met. This may include supporting audit planning, participating in audit execution, and assisting with follow-up on audit findings.
Participates in Design Transfer activities to support successful transfer to external suppliers including CM/OEM.
Supports part qualification strategy (PPAP or other) and works with suppliers to execute the qualification plan.
Assists with process development work with suppliers to deliver capable parts and processes.
Applies foundational knowledge of physics, chemistry, and material behaviors in the evaluation of supplier processes.
May support process validations (IQ/OQ/PQ) and special processes.
Works with suppliers and internal Receiving Inspection teams on inspection and testing methods, MSA/TMVs, product acceptance sampling strategies, and control plans.
Supports supplier performance monitoring and communicates supplier-related issues as they arise.
May assist with non-conforming material reports, supplier change requests, and quality performance reviews.
Supports Corrective Actions and Preventive Actions (CAPA) to help investigate issues, identify root cause, and apply effective actions to prevent recurrence.
Applies a continuous improvement mindset and supports the use of Design for Reliability and Manufacturability (DRM) and Lean Six Sigma (LSS) tools as applicable.
Builds relationships with key stakeholders and contributes positively to a collaborative, cross-functional team environment.
As a Level II, you will work under moderate supervision, developing your technical expertise and growing your ability to independently address quality challenges in a regulated medical device environment.

Benefits

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)
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
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)