Job description
The CompanyAs 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, after an initial training period, for maintaining and improving the metrology process, to manage the calibration supplier working on site, assisting with the design of NPI fixtures and Gage R&R. This position will also assure compliance and provide guidance regarding interpreting governmental regulations (ISO 13485 & FDA standards) with regards to metrology activities.
Key Responsibilities:
This position is primary responsible for the following items that will be learned through on-the-job and formalized training :
1. Coordinating and improving gage retrieval process for external calibration, shop floor returned gage verification, and internal calibration audits
2. Coordinating and assist kitting, check in and check out process for gages
3. Being the primary Metrology contact for the floor and calibration suppliers
4. Developing and managing the calibration supplier and process including the following tasks: approval of the gage certificates, follow up on supplier performance, SCAR submission and follow up, etc.
5. Monitoring and publishing monthly performance of the metrology process
6. Issuing and managing the NCR and SCAR linked to the Metrology process. Coordinating appropriate activities with Manufacturing, QE, and evaluate the risk on production.
7. Centralizing the quoting, acquisition and PO process of gages for the facility
8. Supporting gage R&R activities
9. Supporting CMM Probe calibrations and audits
10. Centralizing information related to trouble shooting for statistical software use, and facilitating their resolution with the support of IT when necessary as per below:
- Metrology QA Technician is responsible for issues escalated by the QAR
- He / She manages the ones linked to the use of the software.
- The issues linked to the software itself (licenses, network, etc.) will be managed by IT; Metrology technician will act as a facilitator / point of contact for IT.
12. Creating or updating QMS documentation aligned with Metrology software.
13. Becoming the Metrology SME.
14. Assisting the QE’s in quoting, procurement, scheduling calibration, and on-time implementation of gages for new projects
15. Assisting in managing customer fixtures and equipment
16. Participating in Lean Red Tag events for fixtures and gages
17. Responsible for linking gage numbers to BOM/Routers and gage certifications to DHRs
Position’s secondary responsibilities are:
1. Train operators on the inspection methods and techniques
2. Participate in internal or external audits
3. Identify continuous improvement, and cost reduction opportunities. Support efforts in order to implement LEAP principles throughout the organization.
4. Design CMM or other fixtures required
5. Other duties as assigned
Required Qualifications:
- A high school diploma or GED and a minimum two years of work experience.
- Proficient PC skills in a Windows environment.
- Effective written and verbal communication skills.
- Strong interpersonal and teamwork skills.
- Experience with gage inspection and CMMs.
- Experience supporting R&R studies.
- Experience working in an ISO environment, preferably ISO 13485.
- Experience using CAD (Solidworks or equivalent) software
- Experience with NCR and SCAR
- Experience in a precision machine shop environment.
- Demonstrated use of structured problem-solving methods (i.e. 8D).
- Experience in internal and supplier audits.
- Experience using an ERP system.
- LEAN / Six Sigma training and demonstrated application.
- 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.
- Normal vision.
- Normal hearing.
- Ability to communicate verbally.
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
No recruiters, please.
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