Quality Systems Manager
Position Description:
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
Basic Qualifications:
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. Must possess at least two (2) years’ experience with each of the following: 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; and Test method Development, Remediation and Validation.
Salary: $164,000 to $211,200 per year
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:
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