Principal Quality Engineer
Principal Quality Engineer
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$ 146000 - 174000
1 Vacancy
Job Description
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 Masters 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: $146000 to 174000 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:
Required Experience:
Staff IC
Employment Type
Full-Time
