Sr. Quality Engineer
Sr. Quality Engineer
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Job Description
Position Description:
Sr. Quality Engineer for Covidien LP (a Medtronic company) located in Irvine CA. Provide quality engineering support for the successful development of Neurovascular products. Ensure design control requirements are met and products are developed and manufactured in accordance with applicable industry standards regulatory requirements and customer requirements. Work with vascular devices embolic coils stents catheters balloons aspiration devices coatings and guide wires to ensure quality products. Utilize Statistical analysis tools including DOE (Design of Experiments) SPC (Statistical Process Control) ANOVA (Analysis of Variance) t-test Process Capability Confidence & Tolerance interval analysis with proficiency in Minitab. Utilize process control tools statistical sampling and other analytical techniques to maximize the quality and flow of product through the production line. Coordinate Product and Process risk utilizing Process Failure Mode Effects and Criticality Analysis (PFMECA) and Design Failure Mode Effects and Criticality Analysis (DFMECA). Navigate government and industry standards to include FDA 21CFR part 820 ISO13485 ISO14971 Good Manufacturing Practices (GMP)and Good Documentation Practices (GDP). Provide Process Verification & Validation for product quality including development and execution of protocols Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) and TMV (Test Method Validations). Coordinate root cause analysis using various quality tools (5 Whys 6M and Ishikawa (Fishbone) Diagram) for failed product or processes. Participate in CAPA (Corrective and Preventive Actions) and implementation of corrective and preventive actions as necessary. Identify Critical to Quality (CTQ) product features procedures for Inspecting testing and evaluating the precision accuracy of products production equipment and sampling methods as well as interpreting engineering drawing and GD&T (Geometric Dimensioning and Tolerancing). Relocation assistance not provided. #LI-DNI
*Position works a hybrid model and will be onsite in Irvine CA location 4/5 days per week. May support 2nd Shift operations 3:00 PM to 12:00 AM.
Basic Qualifications:
Masters degree in Biomedical Engineering Mechanical Engineering Industrial Engineering or related field and two (2) years of experience as a quality engineer manufacturing engineer or in related occupation in quality or manufacturing engineering. Or Bachelors degree in Biomedical Engineering Mechanical Engineering Industrial Engineering or related field and five (5) years of experience as a quality engineer manufacturing engineer or in related occupation in quality or manufacturing engineering. Must possess at least two (2) years experience with each of the following: DOE SPC ANOVA (Analysis of Variance) t-test Process Capability Confidence & Tolerance interval analysis;
Product and Process risk utilizing DFMECA and PFMECA; FDA 21CFR 820 ISO13485 ISO14971 and GDP; Six sigma and lean principles; Process Verification & Validation to include IQ OQ PQ and TMV; Root cause analysis using 5 Whys 6M and Ishikawa (Fishbone) Diagram; CAPA investigation and corrective action implementation; Identifying CTQ product features and sampling methods; Interpreting engineering drawing and GD&T.
Position works a hybrid model and will be onsite in Irvine CA location 4/5 days per week. May support 2nd Shift operations 3:30 PM to 12:00 AM. Relocation assistance not provided.
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
