Quality Inspector (Components)
About The Position
The Quality Inspector is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. Quality Inspectors support manufacturing and servicing operations by performing incoming component and in-process product inspections using standard measurement equipment. They identify, segregate and document rejected material and participate in Material Review Boards to ensure the proper documentation and disposition. They may also review other related Quality documentation such as device history or calibration records.
Requirements
- HS Diploma/GED + 1yr of experience in mechanical inspection or other technical production tasks.
- PC experience and working familiarity of common desktop applications including Excel and Word.
- Ability to work in a fast-paced environment with strict deadlines, generate detailed, high-quality documentation, work with others in analyzing and solving technical problems and perform/manage multiple tasks in parallel.
- Ability to work in a professional manner to support team actions and effectively manages work tasks.
Nice To Haves
- Experience working in a Continuous Improvement (C.I.) or 5S environment.
- Over 1yr of Quality Inspector experience at a Medical Device manufacturing/production company.
- Experience with component inspection, specifically, in medical device production.
- Previous experience documenting information in SAP or similar system.
- Knowledge and working experience using calipers, rulers, and other metallurgy tools.
- Keen eye for detail and process/procedure adherence.
Responsibilities
- Conducts incoming component and in-process product inspections to appropriate standards.
- Identifies, segregates and documents rejected components and materials.
- Participates on a Material Review Board to review and process non conformance reports.
- Supports NC disposition activities such as re-inspection.
- Enters and retrieves inspection and Nc data from local and global systems.
- Reviews related Quality documentation such as DHR’s or calibration records.
- Supports local problem solving activities and may identify opportunities for improvement.
- Complete other duties as assigned.
Benefits
- Market Competitive Pay (bi-weekly).
- Benefits after 30 days.
- Extensive Paid Time Off and added holidays.
- Excellent Healthcare, Dental and Vision Benefits.
- Long/Short Term disability coverage.
- 401(k) with company match.
- Maternity & Paternal Leave.
- Additional add-on benefits/discounts for programs such as Pet Insurance.
- Tuition Reimbursement and continued educations programs.
- Excellent opportunities for advancement and stable long-term career.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
