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:

Masters 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: $164000 to $211200 per year

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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:

Medtronic benefits and compensation plans