Senior Quality Systems Specialist

About the role

In this exciting role as a Sr Quality Systems Specialist you will have responsibility for the Quality and Compliance of process development and manufacturing for implantable Cardiac and Neuromodulation medical device related products at Medtronic's Tempe Campus. Role includes providing a strong partnership with engineering and operations functions to support key Quality initiatives across campus in Tempe's Wafer & Sensor Operations (WSO) and Hybrid Manufacturing Operations areas. Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.

Responsibilities

• Provide oversight for the development, maintenance, and continuous improvement of quality programs, systems, processes, and procedures to ensure compliance with internal policies and external regulations/standards.
• Interpret and provide guidance on regulatory, governmental, and internal requirements; ensure quality processes and documentation meet governing standards.
• Partner with engineering, manufacturing, and other cross-functional teams to ensure quality standards are met across product realization, process development, and ongoing operations.
• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished product, including supporting compliant internal quality procedures and systems.
• Lead and/or support audit and inspection readiness, execution support, and resolution of audit/inspection findings; liaise with auditors/inspectors through all stages of audits.
• Perform process analysis oversight to ensure requirements are enforced and sustained, including monitoring systemic trends, risks, and opportunities for improvement.
• Devises and implements inspection, testing, and evaluation methods for products and production equipment; designs/specifies testing mechanisms; conducts QA testing; and conducts analysis to assess and address nonconformance.
• Support manufacturing development and continuous improvement as the quality representative for process development and validation (including equipment development, IQ, process characterization, OQ/PQ, and test method development/validation).
• Applies use of acceptance criteria to support development of compliant test plans, protocols, and reports.
• Lead and/or support investigations and disposition of nonconforming product/materials/processes, including containment, population identification, documentation, and communication to applicable stakeholders.
• Drive CAPA activities, including investigation support, corrective action implementation, and effectiveness verification; ensure corrective measures meet reliability expectations and documentation requirements.
• Support and drive risk management (e.g., process FMEA) and change control, ensuring thorough assessments and compliant implementation strategies and documentation; develop/maintain quality metrics and reporting (scorecards, issue reporting, performance measures) to guide action and decision-making.

Required Knowledge and Experience

Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Nice to Have

• Experience with electronics manufacturing including wafer fabs and microelectronics assembly (SMT and/or chip and wire).
• Strong background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.
• Six Sigma or Lean Sigma belt certification
• DRM or DFSS certification
• Experience with internal and external audits including FDA, MDSAP and/or TUV.
• 4+ years of experience in a healthcare or medical device manufacturing environment
• Strong understanding of medical device manufacturing processes and products
• Experience with general quality principles, procedures and methodologies
• Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
• Strong statistical analysis techniques & DOE design and execution
• Strong overall communication, both in technical writing and presentation skills, as well as experience with presentation tools and applications

Pay

Salary ranges for U.S (excl. PR) locations (USD): $93,600.00 - $140,400.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Benefits

For 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).

For 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).

Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.