Quality Tech Services, LLC. is a Cretex Medical Company that is a fast-growing dynamic leader within the Twin Cities medical device industry. QTS offers a technical service to assist medical device OEMs throughout the nation with cleanroom assembly and packaging operations. As an employee at QTS, you'll enjoy a culture founded on teamwork, respectful communication, creative problem solving, dependable follow through and excellent customer service.
Ideal Candidate Profile
QTS is currently seeking a full time Quality Engineer to support incoming inspection of all applicable materials. This position will lead, coach, monitor and drive actions in the incoming inspection and materials to assure incoming components meet specifications and available for production, suppliers are performing to QTS standards and the team is working efficiently.
Oversee Inspection processes and Inspection quoting, including supervision and technical support for Receiving inspectors.
Perform QA review and approval of documentation for products (DWG's as well as others.). Including supporting and recommending product control plans to customers based on DWGs's.
Train inspectors on complex inspection setups, methods, techniques, and processes.
Program the Smart Scope inspection routines with setup instruction.
Perform periodic assessment of supplier performance with supply chain and manage and conduct supplier audits.
Complete and lead process improvement initiatives.
Lead environmental monitoring and equipment CAPAs.
Other duties as assigned.
Responsible for personnel activities of assigned direct reports, this includes providing daily work direction as needed, establishing training requirements, managing work schedules and conducting performance evaluations to include goal setting and performance management.
Mentor and develop employee talent
Ensure compliance with current federal, state and local employment regulations. Consult with Human Resources Department as appropriate.
Skills and Experience
Skills and knowledge equivalent to those obtained in a two-year technical program.
Four year degree in technical field preferred.
Computer proficiency and attention to detail.
Proficient in the use of GD&T
Ability to train and mentor inspectors
Supplier audit experience or training.
Knowledge or training pertaining to FDA and ISO regulations.
Knowledge in working with Root Cause Analysis, using quality tools such as Fish Bone Diagramming, Flow Charting and Value Streaming.
Experience programming smart scope or CMM
ISO 13485, FDA 21 CFR 820, MN Board Pharmacy Regulations.
One or more of the following CQA, CQE, CQM, CQT.
2 years medical manufacturing environment experience in a quality-related position preferred.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.
Internal Number: 747563
About Quality Tech Services, LLC
Quality Tech Services, LLC. is a Cretex Medical Company that is a fast-growing dynamic leader within the Twin Cities medical device industry. QTS offers a technical service to assist medical device OEMs throughout the nation with cleanroom assembly and packaging operations. As an employee at QTS, you’ll enjoy a culture founded on teamwork, respectful communication, creative problem solving, dependable follow through and excellent customer service.
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