Quality Systems Manager

Medtronic Inc.•Northridge, CA

54d

About The Position

Quality Systems Manager for Medtronic, Inc. located in Northridge, CA. Provide expertise, guide, and ensure technical rigor in all aspects of Quality Engineering related to manufacturing Site Quality. Plan, coordinate, and execute Medical Device standards activities to ensure the safety and reliability of Medtronic Mini-Med products from concept to end of life. Support standards programs and systems, including both pre-market and post-market product support. Navigate various data analytical tools to deep dive into defect trending and reduce nonconformance. Navigate various standards activities to include standards compliance assessments, identifying applicable standards and portions of standards. Collaborate with the development team to proactively identify and classify risks, ensuring the appropriate translation of standards clauses into product and system requirements, and implementing effective controls to mitigate potential issues. Support various process changes, design changes, new materials and new component engineering change orders. Navigate various government and industry standards for the development and use of medical devices including FDA QSR (Quality Systems Regulations), ISO13485, ISO14971, ISO11135, ISO11737, MDD (Medical Device Directives) 93/42, AIMDD (Active Implantable Medical Device Directives) 90/385, and EU MDR (European Union Medical Device Regulations). Utilize Good Manufacturing Practices (GMP) and risk management activities using FMEA (Failure Mode Effect Analysis). Coordinate Design Control, Design Verification and Process Validation. Lead and oversee root cause investigations, ensuring effective coordination and implementation of Corrective and Preventive Actions (CAPA). Provide for Test method Development, Remediation and Validation. Utilize Excel, Power BI tool, and Minitab for data analytics, process variation, and capability analysis. Relocation assistance not available for this position. #LI-DNI

Requirements

Master's Degree in Mechanical, Biomedical or Industrial Engineering or related engineering field, and 2 years of experience as a quality engineer or related occupation.
Supporting standards programs and systems for both pre-market and post-market product support
Excel, Power BI tool, Minitab for data analytics, process variation, and capability analysis
Supporting process changes, design changes, new materials and new component engineering change orders
FDA QSR, ISO13485, ISO14971, ISO11135, ISO11737, MDD 93/42, AIMDD 90/385, and EU MDR
GMP and risk management activities using FMEA
Design Control, Design Verification, and Process Validation
Root cause investigations and CAPA
Test method Development, Remediation and Validation

Responsibilities

Provide expertise, guide, and ensure technical rigor in all aspects of Quality Engineering related to manufacturing Site Quality.
Plan, coordinate, and execute Medical Device standards activities to ensure the safety and reliability of Medtronic Mini-Med products from concept to end of life.
Support standards programs and systems, including both pre-market and post-market product support.
Navigate various data analytical tools to deep dive into defect trending and reduce nonconformance.
Navigate various standards activities to include standards compliance assessments, identifying applicable standards and portions of standards.
Collaborate with the development team to proactively identify and classify risks, ensuring the appropriate translation of standards clauses into product and system requirements, and implementing effective controls to mitigate potential issues.
Support various process changes, design changes, new materials and new component engineering change orders.
Navigate various government and industry standards for the development and use of medical devices including FDA QSR (Quality Systems Regulations), ISO13485, ISO14971, ISO11135, ISO11737, MDD (Medical Device Directives) 93/42, AIMDD (Active Implantable Medical Device Directives) 90/385, and EU MDR (European Union Medical Device Regulations).
Utilize Good Manufacturing Practices (GMP) and risk management activities using FMEA (Failure Mode Effect Analysis).
Coordinate Design Control, Design Verification and Process Validation.
Lead and oversee root cause investigations, ensuring effective coordination and implementation of Corrective and Preventive Actions (CAPA).
Provide for Test method Development, Remediation and Validation.
Utilize Excel, Power BI tool, and Minitab for data analytics, process variation, and capability analysis.

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