Job description

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 providing strategic, Quality System functional leadership at the plant level, directly supervising a team, overseeing the development and implementation of all manufacturing and project-specific quality plans, managing the CAPA program, administering and overseeing the ISO 13485 and FDA 21CFR820 program, driving quality continuous improvement initiatives, designing and ensuring the appropriate execution of all internal and external quality audits, overseeing the coordinating the Material Review Board, developing, tracking and reporting on all key quality metrics and managing the department budget.

The QA manager has a functional management role over the QAR/QA inspectors, and a direct manager role when the QAR are performing the DHR and/or the final CoC review, which also include the final release or hold of the batch.

Key Responsibilities:
1. Provide strategic-level, quality leadership at the plant, including defining, developing and deploying quality assurance strategies that align with the business objectives and partnering with all departments to ensure proper implementation of these initiatives.
2. Directly supervise a team and oversee the management of all employees in the Quality Department by participating in and overseeing the hiring, work planning and direction, training and performance management processes. Set department priorities for utilization of resources on new programs.
3. Oversee the development and implementation of all manufacturing and project-specific quality plans, including inspection and control plans, and ensure adherence to utilizing Process Failure Mode Effects and Analysis (PFMEA), Gauge Repeatability and Reproducibility (GR&R), Statistical Process Control (SPC) studies and other quality methods and tools as required.
4. Manage the Corrective And Preventative Action (CAPA) program, ensuring the ppropriate root-cause analysis methods are utilized in order to effectively and timely identify and address open issues.
5. Administer and oversee the ISO 13485 program, including ensuring all policies, procedures and work instructions remain updated and are adhered to and all relevant training is delivered.
6. Drive quality continuous improvement initiatives throughout the organization, ensuring LEAN principles and cost reductions are incorporated into all quality strategic initiatives.
7. Design and ensure the appropriate execution of all internal and external quality audits, ensuring recurring completion of and timely resolution of all issues.
8. Oversee and coordinate the Material Review Board, assuring the identification of and appropriate disposition of all non-conforming material.
9. Develop, track, publish and report on all key quality metrics for the business division, ensuring goals are being met and corrective action plans are initiated to address identified issues.
10. Develop and manage the Quality Department budget for the business division.
11. Other duties as assigned.

Required Qualifications:

• Bachelor degree in Manufacturing Engineering or related engineering field; or experience in lieu of a degree.
• Minimum ten years relevant, progressive experience.
• Five years experience supervising a team and managing a Quality Department.
• Experience leading significant business change.
• Broad knowledge base of manufacturing processes, applications, technologies, quality management systems and quality tools (GR&R, PFMEA, SPC, etc.).
• Experience managing an ISO program, preferably ISO13485 and FDA 21CFR820, and conducting internal and supplier audits.
• LEAN / Six Sigma training and demonstrated application.
• Demonstrated use of structured problem-solving methods (i.e. 8D).
• Demonstrated effective leadership skills, including the interpersonal and communication skills necessary to lead people and get results through others.
• Proficient PC skills in a Windows environment.

Preferred Qualifications:

• Experience in the medical device industry
• Experience in a precision machine shop environment.
• Knowledge of laser, CMM and vision systems.
• Experience with supplier quality planning and supplier certification programs.
• MBA.

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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