Quality Systems Manager at Medtronic

Northridge, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Master’s Degree in Mechanical, Biomedical or Industrial Engineering or related engineering field
2 years of experience as a quality engineer or related occupation
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
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, ISO13485, ISO14971, ISO11135, ISO11737, MDD 93/42, AIMDD 90/385, and EU MDR
Utilize Good Manufacturing Practices (GMP) and risk management activities using FMEA
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

Skills

Key technologies and capabilities for this role

ExcelPower BIMinitabFMEACAPAISO13485ISO14971ISO11135ISO11737FDA QSREU MDRGMPDesign ControlProcess ValidationRoot Cause Analysis

Questions & Answers

Common questions about this position

What is the salary range for the Quality Systems Manager position?

The salary range is $164,000 to $211,200 per year.

Is this position remote or onsite, and where is it located?

This is an onsite position located in Northridge, CA. Relocation assistance is not available.

What are the key skills and experience required for this role?

Candidates need a Master’s Degree in Mechanical, Biomedical or Industrial Engineering or related field with 2 years of quality engineering experience, plus 2 years each in standards programs, data analytics with Excel/Power BI/Minitab, FDA QSR/ISO standards, GMP/FMEA, Design Control/Verification/Validation, root cause/CAPA, and test method development.

What standards and regulations will I work with in this role?

The role involves navigating FDA QSR, ISO13485, ISO14971, ISO11135, ISO11737, MDD 93/42, AIMDD 90/385, EU MDR, GMP, and risk management using FMEA.

What qualifications make a strong candidate for this position?

A Master’s Degree in a relevant engineering field with at least 2 years of quality engineering experience and 2 years in each required area like standards support, data analytics tools, regulatory compliance, and CAPA processes will make you a strong candidate.

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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