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Quality Inspector II

1 month ago

Brooklyn Park, United States Cirtec Medical Full time
This position is eligible for a $2,250 Sign-On Bonus

WHO WE ARE:

For over three decades, Cirtec has been an industry-leading outsource partner for complex medical devices. Cirtec Medical provides outsourcing solutions for Class II and III medical devices. From design and development, to precision components and finished device assembly, Cirtec can help bring complex devices to market. Cirtec's expertise includes neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

OUR PEOPLE:

The key to our success is our employees. The extensive design, development and manufacturing experience they provide enables us to create cost-effective, innovative medical device solutions for our customers. Our creative and innovative staff are expert problem solvers and understand the technical, practical and regulatory issues involved in bringing a new or next-generation product to market.

WHY WORK FOR CIRTEC:

With three locations in Brooklyn Park, MN, our employees have the satisfaction of knowing that the work they do helps patients live better, longer lives and their commitment and expertise have made the company it is today: An industry leading provider of life enhancing therapies.

JOB SUMMARY:

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or
test on a wide variety of parts and document results. Indicate inspection status, maintain product
traceability and non-conforming material control. Participate in internal audits, statistical process control
and assist control of process documentation, records, and equipment calibration.

ESSENTIAL RESPONSIBILITIES:
• Inspect, measure and/or test incoming parts, accessories, assemblies, production first piece, in-process, and final product for conformance to specifications, record results and notify appropriate personnel
• Uses drop indicators, calipers, micrometers, profilometers, multimeters, pin gages, thread gages,
thread rings, and other measurement and evaluation-capable equipment for the purposes of assessing conformity to specifications
• Accurately documents and clearly records the results of inspections and testing
• Indicate inspection status of parts with assigned labels and stamps.
• Maintain product identification and traceability.
• Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action
• Presents and/or communicates the status of materials at any time to the Supervisor/Manager
• Communicates the status of materials to engineering
• Protect product during handling and storage in the performance of work.
• Monitor factory environmental conditions, record data and alert adverse conditions.
• Assist with distribution and control of process documentation and quality records.
• Assist with control of measuring and test equipment calibration.
• Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
• Assist with statistical methods of verifying and controlling process capability.
• Provide input when required to quality planning for specific projects and products.
• Provide leadership to production personnel on quality issues.
• Comply with and reinforce the requirements of the Cirtec Quality Management System processes
and procedures, ISO 13485 standard, FDA Quality System Regulations, and other customer requirements.
• Follow Occupational Safety and Health regulations, including laser safety practices.
• Other agreed duties within the Quality Department consistent with training, qualification, and
experience.
• Reliable, consistent, and punctual attendance is an essential function of the job.
• Complies with company, quality, and safety standards, policies, and procedures.
• Other duties as assigned.

WHAT YOU WOULD BRING:
• High school diploma-GED required
• Certificate/s of training related to this field of work (medical or quality assurance) preferred
• 2 years' experience as a Quality Control Inspector in a regulated industry preferred
• Proven experience in inspection and documenting results
• Proficient in the use of microscopes, measuring and test equipment
• Excellent working knowledge of technical drawings, blueprints, specifications, illustrations, and
geometric tolerances
• Able to check dimensions, squareness, hole locations, surface relationships, finish material defects
and mechanical strength of product following appropriate training
• Must be able to read, write and speak fluent English
• Experience in the use of PC's and Microsoft Office software applications
• Prefer experience and familiarity with operations such as cleanroom manufacturing, Swiss machining,
milling, stamping, laser cutting, laser welding, coiling, crimping, swaging, adhesive bonding/backfill,
liquid silicone & thermoplastic injection molding, annealing, and general mechanical assembly.

WHAT WE PROVIDE FOR YOU:
  • Health care and well-being programs including medical, dental, vision, wellness, and Employee Assistance programs
  • Paid time off
  • Training and career development
  • Employee recognition program
  • Tuition assistance
  • 401(k) retirement savings with a company match
  • Ten hour shifts (Monday - Thursday)
  • Clean, climate controlled and well-lit production areas

HOURS:

Monday - Friday (7:00 a.m. - 3:30 p.m.)

WORKING ENVIRONMENT:

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT:

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.