Quality Assurance Specialist

2 weeks ago


Seabrook, New Hampshire, United States ARCH Global Precision company Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at ARCH Global Precision. As a key member of our quality management team, you will be responsible for ensuring that our processes and procedures meet the highest standards of quality and regulatory compliance.

Key Responsibilities
  • Oversee quality assurance activities, including returned goods, customer complaints, corrective actions, and internal audits.
  • Review customer quality agreements and suggest changes to internal procedures to ensure that customer requirements are embodied in our procedures.
  • Monitor conformance of practices to internal procedures through the execution of internal audits and periodic review of key metrics and records.
  • Participate in supplier monitoring meetings and keep abreast of supplier qualification status to ensure that necessary records are obtained prior to addition of supplier to approved list.
  • Work with purchasing to develop annual supplier audit plan and participate in supplier audits.
  • Assist with implementation of new quality initiatives and ensure that quality plans are documented.
  • Keep abreast of regulatory procedures and changes and suggest changes to internal procedures to ensure compliance.
Requirements
  • College degree preferred; High School Diploma or GED required.
  • Minimum of 3 years related experience.
Preferred Qualifications
  • Familiarity with FDA Quality System Regulations and ISO 13485 Standard.
  • Strong computer skills.
  • Strong interpersonal skills, including contributing to a team-oriented environment, balancing team and individual responsibilities, and keeping emotions under control.
Physical Demands
  • Light physical exertion required.
  • Lifting/carrying Maximum lbs: 30.
  • Regularly required to stand, reach, and move about the facility.


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