What are the responsibilities and job description for the Quality Technician I position at Spectrum Plastics Group, A DuPont Business?
Description
SUMMARY:
Responsible for the visual and dimensional inspection of all products according to customer requirements. Responsible for creating and maintaining measurement programs and inspection records. Responsible for maintain/organizing the QMS system.
Key Accountabilities
EXPERIENCE, SKILLS, EDUCATION AND TRAINING:
SUMMARY:
Responsible for the visual and dimensional inspection of all products according to customer requirements. Responsible for creating and maintaining measurement programs and inspection records. Responsible for maintain/organizing the QMS system.
Key Accountabilities
- Assure products are manufactured in compliance with regulatory requirements and manufacturing plans are monitored for compliance to ISO, GMP standards.
- Support inspections (visual and measurements)
- Support Quality Engineers in creating measurement methods and inspection instructions for various products
- 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.
- Assure quality programs are designed to achieve customer specification and continually evaluates quality assurance and/or control methods
- Creating measurement methods and inspection instructions for various products
- Document inspection results by completing reports and logs
- Perform review and closing of Device Master Record
- Assists / Trains operators on part visual acceptability, measurement and processes/procedures as required
- Document quality opportunities / findings through a non-conforming report.
- Quality Engineer support – monitoring Validation runs for compliance to procedure, inspection, gathering/organizing in-process parts and following up on supporting documentation
- Scanning / Maintaining Production Packets
- Scanning / Maintaining Test Order Packets
- Maintaining/Organizing Validation and Production Retains
- Help support various non-normal/test shipping (i.e. sample parts, etc.)
- Support and develop Certificates of Compliance for shipments
- Additional Zeiss support
- Performs all other duties and responsibilities, as assigned.
- Assist Quality Engineers in creating first article format.
- Manage and investigate nonconforming product / MRB to the “Key Responsibilities
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