Principal Quality Assurance Engineer

2 weeks ago

King of Prussia, Pennsylvania, United States Nevro Full time

About Nevro

Nevro is a global medical device company that specializes in delivering comprehensive, life-changing solutions for chronic pain treatment. Our mission is to help patients suffering from debilitating pain, and we've developed proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of over 100,000 patients globally.

Job Summary & Responsibilities

The Principal Quality Assurance Engineer is responsible for managing Quality System activities, including Sustaining Engineering Product Lifecycle Management, Nonconformance investigations, CAPA escalations, Supplier Management, and related Audit files. This is a hands-on role that requires diversified knowledge of Engineering, Risk Management, Supplier Management, and Quality principles and practices for the manufacturing of implantable tissue and medical devices, as well as related surgical tools.

Key Responsibilities

  • Investigate, monitor, document, and trend product and process Nonconformances and Supplier defects.
  • Support ongoing product improvement initiatives.
  • Evaluate and monitor product quality through base business, nonconformance, complaint, and failure investigations.
  • Create and maintain supplier files, draft supplier audit plans, perform remote or on-site supplier audits, write and release supplier audit reports, maintain supplier metrics, and oversee supplier corrective actions.
  • Review and complete supplier change notifications and initiate supplier process improvements as required.
  • Occasional travel to external supplier sites for audits, evaluation, and production support as required.

Requirements

  • Bachelor's degree in engineering, business, technical, or science major.
  • 8-10 years of hands-on Quality experience in the medical device industry.
  • Direct experience working on Class-I or Class-II medical devices, preferably on orthopedic implants, reusable surgical instruments, and human tissue products.
  • Ability to work effectively under minimal supervision.
  • Ability to interpret and apply Quality System Regulations and External Standards.
  • Ability to provide support and guidance to team members across multiple functions and locations.
  • Ability to apply proactive, systematic problem-solving methodologies while identifying, prioritizing, communicating, documenting, and resolving quality issues.

Preferred Qualifications

  • Auditing certification and/or experience in FDA-regulated Class I, II, or III medical device environment following QSR 21 CFR Part 820, QSR 21 CFR Part 1271, EU MDR, and ISO 13485 Quality Systems.
  • Working knowledge of Corrective and Preventive Action methodology and Nonconformity investigations.
  • Process Validation knowledge of IQ, OQ, PQ, Test Method Validation, and Sampling Plans.
  • Practical application of statistical concepts, including SPC techniques, hypothesis testing, DOE, and sampling plans.
  • Excellent presentation skills, including dashboard, summaries, statistical tools, and project planning.
  • Excellent communication, collaboration, and presentation skills.
  • Team player with proven self-accountability, organized, detailed, and adaptable.
  • Strong investigation and problem-solving skills and able to work independently.
  • Knowledge and application of ASQ CQE or Six Sigma tools preferred.

Benefits

Nevro offers a comprehensive benefits package, including market-leading medical, dental, and vision benefits, 401k matching, ample vacation time, pre-tax savings perks, tuition reimbursement, Employee Stock Purchase Plan (ESPP), short and/or long-term incentive opportunities, recognition awards, volunteer time off, and several employee resource groups that focus on supporting our Wellness, Leadership Development, and Diversity and Inclusion.

EEO Statement

Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth, or medical condition related to pregnancy or childbirth), physical or mental condition, protected veteran status, disability, age, or other characteristics protected by laws.

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