Principal Quality Engineer

Position Description:         

Principal Quality Engineer for Medtronic, Inc. located in Northridge, CA. Responsible for product quality of devices within the Diabetes Business Unit. Collaborate with manufacturing, operations quality, regulatory and research & development to ensure therapy continuity for Diabetes patients. Provide Quality Engineering support for Diabetes products ensuring all devices meet necessary compliance, performance, and safety requirements. Navigate the complexity of government and industry regulations to include: 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, and European Union Medical Device Regulation (EU MDR). Responsible for evaluating non-conformances and issue Product Hold Orders to control product distribution. Responsible for the assessment, generation and maintenance of risk mgmt. documentation including Risk Assessment Documents (RAD), Risk Mgmt. Reports (RMR), Failure Modes Effects Analysis (FMEA) and provide technical evaluations and risk assessments for on-market products / systems. Responsible for Corrective and Preventative Actions (CAPA) as well as providing Technical Engineering support to larger CAPA teams. Leverage Process Improvement Tools to include DMAIC (Define, Measure, Analyze, Improve and Control), Root Cause Analysis, 5Whys, Fishbone, and cause mapping. Provide engineering support for internal and external Quality Mgmt. and regulatory audits. Position works a hybrid model and will be onsite in Northridge, CA – at least 3 days per week.  #LI-DNI.

Basic Qualifications:          

Requires a Master’s degree in Engineering Management, Mechanical Engineering, Industrial Engineering or related engineering field and four (4) years of experience as a Manufacturing, Quality or Validation Engineer or related occupation for medical devices. Must possess at least four (4) years’ experience with each of the following: 21 CFR Part 820 QSR, ISO 13485, and EU MDR; Risk assessments, evaluating impact of product non-conformances, and issuing product hold orders; Assessment, generation and maintenance of risk mgmt. documentation incl. RAD, RMR, and FMEA; CAPA; DMAIC, Root Cause Analysis, 5Whys, Fishbone, and cause mapping; and Quality Mgmt. and Regulatory audit.

Salary: $146,000 to 174,000 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:

Medtronic benefits and compensation plans