Quality Engineer - Manufacturing

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: This position is responsible for assisting production, work on continuous improvement on the shop floor, managing the customer complaints and the CAPA/NCR linked to his/her scope of activities, leading Change Request with the Customers, assuring compliance to and providing guidance regarding interpreting ISO 13485, FDA and applicable standards/requirements in link with the Manufacturing Quality Engineer activities.

Key Responsibilities:

1.For the Quality topics, assisting production and participating to achieve the APU objectives defined with the Production.

• Identify continuous improvement opportunities and support efforts in order to implement LEAP principles throughout the organization, such as participating to PSM or LEAP workshop.

• The NCR and the CAPA management from creation to closure, especially linked to customer complaints or multifactorial causes, in respect with due dates defined and using problem solving tools when applicable. Working as part of a cross-functional team. Interface (Lead) with the customer in case of Customer complaints or supplier SCAR.

• Participate and act as the QA lead for the equipment validation.

• Participate and act as the QA lead for changes that will occurred in production, in respect with Customer Agreement, ISO standard and internal requirements.Prepare, submit and follow Change Request (SCR) with customers.

• 6 sigma, statistical technics and 8D problem solving SME.

• Perform internal or external audits.

• Implement drawing revision with the project team if it has been delegated by the NPI QEs.

• Create/Maintain updated quality plans and work instructions, inspection and control plans, inspection work instruction, PFMEA,… including the respect of quality requirements and standards.

• Compile and analyze statistical data in order to assess process capabilities and control processes and conduct Process Failure Mode Effects and Analysis (PFMEA), Gauge Repeatability and Reproducibility (GR&R) and Statistical Process Control (SPC) studies.

• Support as needed the weekly QAR internal meeting (PSM1), help to harmonize the QAR practices, escalation of issues when applicable.

• Be the backup of the Manufacturing QE or QA technician.

Required Qualifications:

• Bachelor degree in Manufacturing Engineering or related field.

• Minimum two years relevant experience / five years for senior position.

• Blueprint reading is mandatory - GDNT level expected

• Experience working on CAPA.

• Experience developing manufacturing quality plans.

• Experience conducting process capability, GR&R, PFMEA and SPC studies.

• 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 optimizing processes to achieve ongoing cost reductions.

• Experience in a precision machine shop environment.

• 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

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.