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Medical Device Company - QA/QC Specialist

This Jobot Job is hosted by: Victoria CasalAre you a fit? Easy Apply now by clicking the "Quick Apply" button and sending us your resume.Salary: $28 - $32 per hour

A bit about us:

A global provider of isotope-based technology, developing and manufacturing products used in medical, scientific, and industrial applications.

Why join us?

Competitive BaseRoom for advancementFull Benefits401Kand more...

Job Details

Key ResponsibilitiesWork under the direction of the Quality Systems, Regulatory, or Radioassay leadership to support and maintain compliance with established quality programs.Provide regular updates on QA and QC activities through reports and team discussions.Support the upkeep of a compliant Quality Management System aligned with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR 820, NRC, BIS, DOT, ISO 17025, CE Mark, and other applicable regulatory standards.Assist with ongoing regulatory compliance requirements and updates as needed.Perform final quality checks across product lines and review outgoing orders, with exceptions as directed by leadership.Manage nonconformance reports (NCRs), including issuance, tracking, resolution, and documentation.Maintain accurate filing and organization of all quality records and documentation.Monitor production activities to ensure adherence to established procedures.Identify opportunities for process improvements and recommend updates where appropriate.Conduct incoming inspections of materials and components.Verify accuracy and readability of engravings completed internally or by external vendors.Support dimensional inspections of manufactured components.Review domestic and international orders for regulatory and license compliance.Assist in managing document control systems and processes.Update and revise quality documentation, including procedures, forms, drawings, and records.Maintain documentation systems and tools such as BPM platforms, eQMS, or document management software.Support approval of design documentation and engineering change orders.Contribute to the maintenance of technical files for regulated products.Participate in internal and supplier audits under the supervision of a lead auditor.Provide training to staff on quality procedures and inspection methods as needed.Travel periodically between local facilities and to supplier sites for audits or training.Perform additional responsibilities as assigned.

QualificationsHigh school diploma required; associate or bachelor’s degree preferred.At least 3 years of experience in quality control or quality assurance.Prior exposure to documentation control, record keeping, or inventory tracking is preferred.

Skills and ExperienceStrong written and verbal communication skills.High level of attention to detail and accuracy.Experience using inspection tools such as calipers, micrometers, and optical measurement equipment.Ability to perform final inspections and receiving inspections independently.Comfortable working both independently and collaboratively.Strong organizational skills with the ability to manage shifting priorities.Proficient in Microsoft Excel, Word, and Access.Ability to lift up to 50 pounds.Willingness to travel between local sites as needed.

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