Summary
Location
Mebane
Type
full-time
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About this role
Description
Essential Functions and Priorities
- Review in-process inspections before filling.
- Communication about quality issues.
- Communication and, if necessary, elevation of quality concerns to the Quality Manager or other quality personnel.
- Coordinate label information and ensure correct labels are available.
- File and organize quality and production files needed for production.
- Prepare outgoing certifications and documentation as required.
- Review line clearance and elevate issues as required.
- Perform inspection duties as required.
- Review quality on the floor and address or elevate quality issues.
- Responsibility for maintaining the Quality Laboratory and communicating any need for supplies/services.
- Responsible for preliminary investigations into parts that have quality concerns.
- Other duties as assigned.
Requirements
Work Standards
- Able to Work independently.
- Good understanding of area/products assigned.
- Good Communication Skills.
- Critical Thinking Skills.
- Understanding of Quality Plans (QP)
Experience:
- Previous experience in Quality in a manufacturing setting – Preferred
Education
- High School/Equivalent preferred
Training
- Instruction/Training in pertinent areas related to position
- Good Manufacturing Practices (GMP)
- Good Documentation Practices (GDP)
Other facts
About BIOMERICS LLC
Founded in 1994, Biomerics is the leading vertically integrated medical device contract manufacturer serving the interventional device market. Trusted as a vertically integrated partner with extensive engineering expertise and solutions, Biomerics supplies 20 of the top 30 medical device OEMs globally. Biomerics provides engineering design and development services, technology transfer manufacturing services and contract manufacturing services — including sterilization and packaging — for medical device components, subassemblies and finished medical devices. Through nine locations in the United States, two locations in Costa Rica, one in the Dominican Republic and one in Ireland, Biomerics meets customers’ immediate and long-term strategic needs. With comprehensive engineering Centers of Excellence, Biomerics is a leader in materials, interventional medical plastics, complex extrusion, micromachining of metals and polymers, laser processing, guidewires, balloons and balloon catheters, advanced catheters and steerables, image guided intervention, micro-overmolding, micro precision stamping, complex microassembly and finished device assembly. In addition to operating under a certified ISO 13485:2016 quality system, Biomerics is FDA registered and compliant with FDA 21 CFR Part 820.
Markets we serve:
- Cardiovascular
- Endoscopy
- Neuromodulation
- Neurovascular
- Robotic Surgery
- Structural Heart
- Urology
- Vascular Access
What you'll do
- The coordinator is responsible for reviewing in-process inspections, managing quality communications, and ensuring correct labeling and documentation are filed for production. This role also involves performing floor quality reviews and preliminary investigations into quality concerns.
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