Senior Quality Engineer
Senior Quality Engineer
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Job Description
Position Description:
Senior Quality Engineer for Covidien LP (a Medtronic company) located in Irvine CA. Responsible for ensuring the quality and compliance of the manufacturing processes for a variety of vascular devices such as embolic coils stents catheters balloons aspiration devices coatings and guide wires. Leverage Good Manufacturing Practices (GMP) standards and navigate the complexity of government and medical device industry regulations including FDA 21 CFR Part 820 ISO 13485 ISO 14971 and ISO 9001 standards to ensure products are consistently produced per the quality standards. Coordinate risk mgmt. activities in manufacturing utilizing PFMECA to identify and mitigate risks in manufacturing processes. Responsible for risk assessments to ensure thorough identification and evaluation of manufacturing risks. Coordinate Process Verification and Validation activities by conducting Installation Qualification (IQ) Operational Qualification (OQ) and Process Qualification (PQ) to verify and validate manufacturing equipment and processes. Implement Test Method Validation (TMV) to ensure the reliability of manufacturing test methods. Leverage critical analysis skills and Quality tools including 5 Whys 6M Ishikawa Diagram and Pareto Charts for root cause analysis of the manufacturing processes. Utilize Lean Six Sigma principles to streamline manufacturing processes and enhance efficiency. Responsible Corrective and Preventive Actions (CAPA) and Non-Conforming Material Report (NCMR) of manufacturing processes by coordinating activities focused on addressing manufacturing non-conformances determining root causes and implementing corrective and preventive actions. Utilize statistical analysis skillset in the manufacturing domain leveraging statistical analysis tools for process capability and measurement system analysis be able to utilize software including Minitab to support manufacturing decisions. Apply Geometric Dimensioning and Tolerancing (GD&T) in the context of manufacturing to ensure parts are produced within specified tolerances. Responsible for generating and managing manufacturing documentation including specifications procedures and sampling methods. Responsible for providing engineering coverage across various shifts including (1st and 2nd shifts) and providing continuous quality engineering support to the manufacturing operations. #LI-DNI
Basic Qualifications:
Masters degree in Biomedical Mechanical Industrial Engineering or related engineering field and two (2) years of experience as a Quality Engineer or related quality engineering occupation or Bachelors degree in Biomedical Mechanical Industrial Engineering or related engineering field and five (5) years of experience as a Quality Engineer or related quality engineering occupation. Must possess a minimum of two (2) years of experience with each of the following: FDA 21 CFR Part 820 ISO 13485 ISO 14971 & ISO 9001; Good Manufacturing Practices (GMP); Risk activities using FMECA including DFMECA and PFMECA; IQ/OQ/PQ and Test Method Validation (TMV); Root cause investigations 5 Whys 6M Ishikawa Diagram and Pareto Charts; Lean 6 Sigma; CAPA & NCMR; Minitab; and GD&T. Must be able to work/cover across both 1st and 2nd shifts.
Salary: $130600 to $145200 per year
#LI-DNI
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
Required Experience:
Senior IC
Employment Type
Full-Time
