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 Plymouth MN. Responsible for ensuring the quality and compliance of the manufacturing processes for a variety of vascular devices including 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 EU-MDR and BSI 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 DMAIC 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 SPC 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. #LI-DNI
Basic Qualifications:
Requires a Masters degree in Industrial and Systems Engineering Biomedical or Mechanical Engineering or related engineering field and two years of experience as a Quality Engineer or related occupation in quality engineering; or Bachelors degree in Industrial and Systems Engineering Biomedical or Mechanical Engineering or related engineering field and five years of experience as a Quality Engineer or related occupation in quality engineering. Must possess at least two (2) years experience with each of the following: FDA 21 CFR Part 820 ISO 13485 EU-MDR and BSI; Good Manufacturing Practices (GMP); Risk activities using FMECA including DFMECA and PFMECA; IQ/OQ/PQ and Test Method Validation (TMV); Root cause investigations DMAIC 5 Whys 6M Ishikawa Diagram and Pareto Charts; Lean 6 Sigma; CAPA & NCMR; Minitab and SPC; GD&T.
Position works a hybrid model requiring the employee to be onsite in Plymouth MN at least 3-4 days per week.
Salary: $121400 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
