Spherion is looking for a quality control technician for a state of the art facility that manufactures the world's best prosthetic, orthotic and medical products.
The candidate is responsible to ensure compliant processing of Device History Records (DHR's) and perform final release of product. The candidate is responsible for inspection of purchased incoming
components as required by their specifications. The candidate is responsible for maintaining the calibration of our measuring devices as required by their specifications. Support the Quality Team in
maintaining, implementing, and improving the Quality Systems as required in accordance with FDA 21 CFR Part 820 as well as Global Standard ISO 13485:2016.
??? Responsible for reviewing Device History Records (DHR???s) and corresponding documentation to
comply with FDA requirement 820.80 and 820.184 as well as Global Standard ISO 13485:2016
??7.5.1 to release finished product.
??? Responsible for inspection of components and corresponding documentation to comply with FDA
requirement 820.72 and 820.90 as well as Global Standard ISO 13485:2016 ??7.4.3 and release
??? Perform Incoming Inspections of components to critical dimensions per specification and/or
??? Understand and use measurement instruments appropriately
??? Ensure proper calibration and verification of inspection for production tools and equipment
??? Assure complete and accurate records are retained.
??? Identify and track nonconformities found.
??? Responsible for coordinating equipment due for calibration with equipment owners and ensuring
equipment is calibrated in a timely fashion per FDA 820.72 and ISO 13485:2016 ??7.6
??? Work with production to ensure adequate understanding of Device History Records and Good
??? Support the Quality Team in maintaining, implementing, and improving the Quality System.
??? Willingness to lead by example and teach others.
??? Maintain Clean and safe work environment
??? Other tasks and duties as assigned.
Working hours: 7:00 AM - 4:30 PM
- Competent team-worker.
- Great attention to detail.
- Good communication skills.
- Ability to read and write English fluently.
- Preferable experience in Medical Device industry.
- Preferable knowledge of FDA regulations and ISO standards.
- GD&T fundamentals experience preferred
- High School Diploma (or GED).
- Background check and drug screen
- QA / QC experience
Call 801-280-8880 or text QUALITY to set up an interview. You can also send resumes to firstname.lastname@example.org
Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact Callcenter@spherion.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including health, and an incentive and recognition program (all benefits are based on eligibility).
For certain assignments, Covid-19 vaccination and/or testing may be required by Spherion's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Spherion representative for more information.