Supplier Quality Engineer

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, ensure that product and service from vendors and supplier are align with standards, managing the supplier performance and the CAPA/NCR linked to his/her scope of activities, leading Change Request, assuring compliance to and providing guidance regarding interpreting ISO 13485, FDA and applicable standards/requirements in link with the Supplier Quality Engineer activities.

Responsibilities

• Evaluates, investigates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues
• Reviews and approves supplier corrective action plans and verification of effectiveness documentation
• Coordinates the evaluation of proposed changes at suppliers
• Plans and leads audits of suppliers to assess compliance with regulatory and Lisi Medical Remmele requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up
• Proactively assesses supplier capabilities through direct on-site visits and technical discussions
• Collaborate with cross-functional new product development teams to onboard suppliers
• Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations
• Generates and maintains incoming inspection procedures
• Assists in generating component specifications, Develops acceptance criteria for materials
• Approve Supplier on the ASL and maintain accurate documentation related to supplier quality activities.
• Lead and monitor Suppliers performance assessment

Required Qualifications:

• Bachelor degree in Manufacturing Engineering or related field.   
• At least 5+ years of Quality Engineering experience in medical device
• At least 2 years of experience specifically in Supplier Quality
• Blueprint reading is mandatory – GDNT level expected
• Experienced in Problem Solving methodologies and CAPA
• Experience qualifying, auditing and managing supplier in medical device
• Experience with validations (IQ,OQ,PQ)
• Experience conducting process capability, GR&R, PFMEA and SPC studies.   
• Detailed knowledge of FDA, GMP, ISO 13485
• Solid communication and interpersonal skills, computer skills
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail
• Ability to travel estimated up to 10%

Preferred Qualifications:         

• Experience optimizing processes to achieve ongoing cost reductions.
• Experience in a precision machine shop environment.
• LEAN / Six Sigma training and demonstrated application. 

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.