Teleflex - Chelmsford, MA

posted 25 days ago

Full-time
Chelmsford, MA
Miscellaneous Manufacturing

About the position

With limited supervision performs quality inspections for IAB-C. Assists the QC Supervisor, QA Engineer and/or Quality Manager in the required areas as listed in Principal Responsibilities.

Responsibilities

  • Compliance to all work instructions, Quality regulations, SOP's, WI's, GMP's and GDP's in the effort to manufacture high quality medical devices at all times.
  • Training: As required, will train employees to inspection requirements and techniques in manufacturing or other areas.
  • Retrieval of documentation or work instructions through Agile as necessary, to perform inspections.
  • Reviews orders and job packets, recording batch numbers and quantities, as required by inventory system.
  • Communication: shares instructions and knowledge with other inspectors or employees within the quality department.
  • Records results in a legible and accurate manner.
  • Reads, interprets and applies dimensional or other requirements defined in work instructions, process documents or graphics.
  • Provides support for special projects and assignments, including work in areas such as validations, nonconformance investigations and CAPAs.
  • Serves on and is actively involved in cross-functional teams. Interface, when needed, with various levels of manufacturing or engineering regarding quality issues.
  • Uses required tools and instruments (i.e. caliper, plug gauges, multimeter, microscope, and micrometer) to measure, assess or analyze quality attributes.
  • Inspect IAB and RH sub-assemblies and assemblies for cosmetic and physical flaws and/or perform electrical, mechanical and visual inspections of sub-assemblies and final assemblies.
  • Support in process and Final Inspection.
  • Adhere to and ensure the compliance of Teleflex's Code of Ethics, all company policies, rules, procedures and housekeeping standards.

Requirements

  • High School Diploma/GED
  • Minimum of six months of quality experience, preferably in medical device.
  • Experience with Quality Management Systems (ISO 13485 and Medical Device Regulations (21 CFR 820).
  • Must possess Quality job knowledge, including inspection, testing and record keeping.
  • Must be proficient in basic computer skills, Microsoft Office and SAP experience preferred.
  • Excellent Communication Skills
  • Must be extremely detail-oriented.
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