Job Description

Description

SUMMARY:

KEY ACCOUNTABILITIES:

1. Assure products are manufactured in compliance with regulatory requirements and manufacturing plans are monitored for compliance to ISO, GMP standards.
2. Support inspections (visual and measurements)
3. Support Quality Engineers in creating measurement methods and inspection instructions for various products

KEY RESPONSIBILITIES:

1. May perform dimensional and visual inspection (dimensions such as length, height, contamination, and distance) using precision instruments such as micrometers, calipers, dial indicator, Micro Vu and CMM to ensure product meets specifications.
2. Assure quality programs are designed to achieve customer specification and continually evaluates quality assurance and/or control methods
3. Creating measurement methods and inspection instructions for various products
4. Document inspection results by completing reports and logs
5. Perform review and closing of Device Master Record
6. Assists / Trains operators on part visual acceptability, measurement and processes/procedures as required
7. Document quality opportunities / findings through a non-conforming report.
8. Quality Engineer support – monitoring Validation runs for compliance to procedure, inspection, gathering/organizing in-process parts and following up on supporting documentation
9. Scanning / Maintaining Production Packets
10. Scanning / Maintaining Test Order Packets
11. Maintaining/Organizing Validation and Production Retains
12. Help support various non-normal/test shipping (i.e. sample parts, etc.)
13. Support and develop Certificates of Compliance for shipments
14. Additional Zeiss support
15. Performs all other duties and responsibilities, as assigned.
16. Assist Quality Engineers in creating first article format.  
17. Manage and investigate nonconforming product / MRB to the “Key Responsibilities

Qualifications

EXPERIENCE, SKILLS, EDUCATION AND TRAINING:

• Associate Degree or equivalent preferred, or 2-3 years’ related experience/training, or equivalent combination of education and experience in inspection in the medical device industry
• Strong Computer skills; Microsoft Office (Word, Excel) and Minitab
• Must have a strong attention to details and highly organized
• Leadership skills and team player
• Ability to work in a fast-paced, team environment.
• Strong written, verbal, time management and interpersonal skills
• Mechanical aptitude required 

• High level of accountability aligned with our policy of Promises Made – Promises Kept.
• Ability to read, analyze and interpret inspection reports and technical information documents
• Ability to effectively present information in a clear and concise manner to top management or personnel groups
• Ability to define problems, collect data, establish facts and draw valid conclusions
• Visibility requires maintaining a professional appearance and providing a positive company image to the public