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QA Engineer

QA Engineer

LISICoon Rapids, MN, United States
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The Company

As world leader in the design and production of industry solutions, the three divisions of LISI group (LISI AEROSPACE, LISI AUTOMOTIVE and LISI MEDICAL) employ more than 10,000 people in 13 countries. With its headquarters in France, LISI MEDICAL is an innovative subcontractor specializing in the manufacture of implants and instruments for minimally invasive, orthopedic, spinal and traumatological surgery.

More than a part.

LISI MEDICAL , is recognized for delivering quality products and innovative services to our customers. Committed to its reputation, LISI MEDICAL ensures agile management of development projects, remarkable industrial capacities, and expertise.

Through mastery of manufacturing technologies (machining, forging, surface treatments, heat treatment, automation), products designed by our customers are built through optimized production processes to ensure precision.

The Minnesota (USA) entity, with two production sites located in Coon Rapids and Big Lake, MN, offers expertise and innovation in the manufacture of instruments for robotic surgery and osteosynthesis implants. We offer a clean production environment, an excellent benefit and compensation package along with a strong company culture where we are committed to our clients to improve the quality of life of patients.

Competitive Benefits Include : medical, dental, vision, life insurance, paid time off and 401K. Tuition reimbursement to support your development; floating holidays that you take for days that are important to you.

Come Join Our Team!

Position Summary :

The Quality Engineer is responsible for developing new processes / products, validating new equipment and technology, assisting production with continuous improvement on the shop floor, managing customer complaints, and handling CAPA / NCR activities. This role also involves leading change requests with customers and ensuring compliance with ISO 13485, FDA, and other applicable standards. The Quality Engineer collaborates closely with QA Technicians and Quality Inspectors (QAR).

Key Responsibilities :

1. Process and Product Development :

  • Develop new processes / products and revise existing ones.
  • Create and update project-specific quality plans, ensuring adherence to customer requirements.
  • Work as part of a cross-functional team.
  • Develop methods to measure products to ensure they meet quality standards.
  • Troubleshoot measurement methods and equipment to ensure accuracy and reliability.

2. Validation :

  • Lead validation of new products and technology (IQ, OQ, PQ).
  • Act as QA lead for equipment validation.

    • 3. Customer and Supplier Interface :

  • Collaborate with customers and suppliers on new product processes.
  • Lead customer complaints and supplier SCAR management.

    • 4. Statistical Analysis :

  • Compile and analyze statistical data to assess process capabilities.
  • Conduct PFMEA, GR&R, and SPC studies.

    • 5. Quality System Documentation :

  • Create and maintain quality system documentation, including quality plans, inspection and control plans, and work instructions.

    • 6. NCR and CAPA Management :

  • Manage NCR, CAPA, and customer complaints from creation to closure.
  • Use problem-solving tools and work as part of a cross-functional team.

    • 7. Change Management :

  • Lead changes in production, ensuring compliance with customer agreements, ISO standards, and internal requirements.
  • Prepare, submit, and follow change requests (SCR) with customers.

    • 8. Production Support :

  • Assist production in achieving APU objectives.
  • Generate quality KPIs for PSM2.

    • 9. Audits :

  • Perform internal and external audits.

    • 10. Secondary Responsibilities :

    11. Backup Support :

  • Serve as backup for other QEs on customer or internal tasks as requested by the QA manager.

    • 12. Continuous Improvement :

  • Identify and support continuous improvement opportunities.
  • Participate in LEAP workshops.

    • 13. Training :

  • Contribute to employee training.

    • 14. Other Duties :

  • Perform other duties as assigned.

    • Note : The Quality Engineer has a functional link with the QAR / QA inspectors.

    In case of any issue escalated by the QAR about the DHR final acceptance and / or final CoC, the QE has authority to release or hold the DHR, approve the final CoC and / or decide the final status of the parts and release or hold the batch.

    They can also escalate to the QA manager.

    Health, Safety & Environment responsibilities and skills :

  • Participate in the development and promotion of the HSE culture
  • Be exemplary in terms of health, safety and the environment, in particular by :

    • o Respecting and ensuring respect for the instructions and rules established in the field of health, safety and the environment (in particular the LISI golden rules)

    o Immediately correcting, whenever possible, or reporting to his or her superiors and / or the HSE department, any malfunction or risky situation in the fields of health, safety and environmental protection

    o Implementing preventive actions to reduce the environmental footprint and control health and safety risks

  • Participate, upon request, in analyses (of risks, incidents) and HSE working groups related to his / her professional scope
  • Be familiar with the main health and safety risks and the main environmental impacts relating to the scope of his / her work
  • Be familiar with the site's HSE policy and objectives
  • To be able to make proposals for improving working conditions and limiting environmental impact

    • Required Qualifications :

  • Bachelor degree in Manufacturing Engineering or related field.
  • Minimum two years relevant experience / five years for senior position.
  • Blueprint reading is mandatory - GD&T level expected
  • Experience developing manufacturing quality plans.
  • Experience conducting process capability, GR&R, PFMEA and SPC studies.
  • Experience working on NCR / CAPA.
  • Experience working in an ISO environment, preferably ISO 13485.
  • Proficient PC skills in a Windows environment.
  • Effective written and verbal communication skills.
  • Strong interpersonal and teamwork skills.

    • Preferred Qualifications :

  • Experience in a precision machine shop environment.
  • Experience optimizing processes to achieve ongoing cost reductions.
  • LEAN / Six Sigma training and demonstrated application.
  • Demonstrated use of structured problem-solving methods (i.e. 8D).
  • Experience in internal and supplier audits.
  • Experience using an ERP system.
  • Experience of managing a staff or cross functional team lead for senior position

    • Physical Demands

  • Must be able to sit, grasp items and perform keyboarding frequently.
  • Must be able to reach, stretch and occasionally lift up to 30 lbs.
  • Must be able to travel occasionally.

    • Sensory Requirements

  • Normal vision.
  • Normal hearing.
  • Ability to communicate verbally.

    • Compensation and Benefits Overview

    Starting Pay Range for this position is $80,000 -$95,000 Annually

    Minimum pay rates offered will comply with applicable county or city regulations if they exceed the listed range. Actual pay rates are determined based on various factors, including but not limited to, local labor market conditions, years of relevant experience, education, professional certifications, foreign language proficiency, and other job-specific qualifications.

    Employees and their families are eligible to participate in a comprehensive benefits package, including company-sponsored medical, dental, vision, flexible spending accounts (FSA), health savings accounts (HSA), voluntary benefits, supplemental life / AD&D insurance, and the company's 401(k) plan. Additional benefits include access to an employee assistance program (EAP) for employees and household members, long-term disability coverage, and short-term disability for full-time employees.

    Full-time and Part-time employees receive Paid Time Off (PTO) based on years of service, as well as paid holidays, personal holidays and MN Safe and Sick Time.

    LISI MEDICAL Remmele is an equal opportunity at will employer and does not discriminate against any employee or applicant for employment because of age, race, religion, color, disability, sex, sexual orientation or national origin.

    We maintain a drug-free workplace and perform pre-employment substance abuse testing.

    No recruiters, please.

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    Qa Engineer • Coon Rapids, MN, United States