Quality Technician
About The Position
The Quality Technician 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. The Quality Technician supports manufacturing and servicing operations by assisting in performing and documenting problem-solving investigations and conducting in-process sub-assembly and final QC product acceptance testing. Quality Technicians assist in identifying and documenting process and product non-conformances. They work with operations team members to perform and document problem-solving investigations. In addition, Quality Technicians may review device history records, authorize release of finished product/processes and execute calibration and environmental monitoring processes.
Requirements
- Minimum of three (3) years of experience in a manufacturing or repair environment or other technical production tasks with a high school diploma or equivalent.
- Minimum of one (1) year of experience in a manufacturing or repair environment or other technical production tasks with an associate degree.
- Ability to work in a fast-paced environment with strict deadlines.
- Ability to generate detailed, high-quality documentation.
- Ability to work with others in analyzing and solving technical problems.
- PC experience and working familiarity of common desktop applications including Excel and Word.
- Experience with mathematical skills including ratios, proportions and basic algebra.
Nice To Haves
- Experience working in a chemical manufacturing/production environment.
- Continuous Improvement/Process Improvement experience.
- Attention to detail.
- Hazardous materials experience.
- Experience working with FDA (CFRA20/GMP&GDP) and/or ISO or similarly regulations.
- Experience utilizing Trackwise, SAP, Propel systems.
Responsibilities
- Assists in production line Quality investigations and associated problem-solving activities.
- May coordinate and conduct in-process and final QC product acceptance testing, depending on facility.
- Investigates production line stoppages to identify corrective actions.
- Identifies and documents product and process non-conformances.
- Participates on a Material Review Board to review and process non conformance reports.
- Reviews DHR’s and supports batch record release.
- Enters and retrieves Quality data from local and global systems.
- Performs site calibration activities and recordkeeping.
- Executes environmental monitoring processes and recordkeeping.
- Verifies calculations, dose ranges, dosimeter placements and special instructions prior to processing and part of final product release.
Benefits
- Market competitive pay.
- Extensive Paid Time Off (PTO) and (9) added Holidays.
- Excellent Healthcare, Dental, and Vision Benefits.
- Long/Short term disability coverage.
- 401(k) with a company match.
- Maternity & Parental Leave.
- Additional add-on benefits/discounts for programs such as Pet Insurance.
- Tuition Reimbursement and continued education programs.
- Opportunity for advancement in a stable long-term career.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
