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Title:

Quality Assurance Coordinator Work Model:

100% onsite

Schedule:

Monday - Friday, 1st shift

Description:

A leading biomedical manufacturing organization is seeking an experienced Quality Assurance Coordinator to support quality control and inspection activities within a Lifecycle NPI environment. This is a hands-on quality role for someone with strong experience in inspection, metrology, non-conforming material, calibration, and regulated quality systems . What You'll Do Perform detailed product inspections in accordance with SOPs and design specifications. Conduct incoming material inspections using vision inspection systems, including Keyence . Generate and document Non-Conforming Material Reports (NCMRs) when products or materials do not meet specifications. Create, maintain, and organize inspection records and retain samples. Verify inspection and test equipment is properly calibrated. Use critical thinking and problem-solving skills to identify opportunities for process improvement. Support additional quality-related activities and projects as assigned. What We're Looking For 5+ years of Quality Control experience in the biomedical/medical device industry. Hands-on experience with metrology inspection equipment . Experience with SAP or another ERP system . Working knowledge of regulated quality systems, including:

ISO 9001

2015 ISO 13485:2016 21 CFR 820 Proficiency with inspection tools such as calipers, gauges, and related measurement equipment . Strong attention to detail and ability to identify quality issues. Excellent problem-solving, organizational, written, and verbal communication skills. Proficiency with Microsoft Excel and Word . Ability to work effectively in a team environment. Ability to lift and/or move up to 50 lbs. Education High School Diploma or equivalent required. Why Consider This Opportunity? Join a quality-focused team within a regulated biomedical manufacturing environment . Gain exposure to new product introduction (NPI), inspection, metrology, and quality systems . Monday-Friday schedule with a consistent 40-hour workweek . #CNX200

Pay:

$24.00 - $27.58 per hour

Benefits:

Dental insurance Health insurance

Education:

High school or equivalent (Required)

Experience:

quality control in the biomedical industry: 5 years (Required) metrology inspection equipment: 2 years (Required) SAP or ERP systems: 1 year (Required)

ISO 9001, ISO

13485 and 21 CFR 820: 1 year (Required)

Word and Excel:

3 years (Required) calipers, gauges and inspection equipment: 3 years (Preferred)

Work Location:

In person