Quality Assurance Specialist

Company: Midmark Corporation

Position: Quality Assurance Specialist

Location: Torrance, California

Posted: May 2, 2020

Job Type: Fulltime
Contact Name: Sandra Dancy
Phone: 310-516-5104
Fax: 937-526-7550
Email: [email protected]
Salary: $67,000

Job Description

Administers and maintains Midmark Corporations’ regulated Document Control, and Customer feedback processes, manual and electronic, in accordance with FDA and ISO regulation by performing the following duties.

  • Coordinate the Engineering Change Orders (ECO) process, ensuring update, prompt release, and distribution of related documents and files
  • Ensure that all documents and or part numbers are issued according to the prescribed part numbering and or document numbering schemes. Key; review all relevant QP as numbers are issued to ensure compliance
  • Ensure that Controlled Document Logs are created for all controlled records; QP, WI, travelers, manufacturing procedures, quality forms, etc. Ensure updates are done promptly and accurately
  • Quality Record Management forms must be created for all quality records; maintain Quality Records Management forms; update promptly and accurately
  • Process changes/updates to the NPD templates in accordance with ECO procedures; reference NPD WI
  • Assist Quality System Supervisor in gathering raw data for failure analysis/trending, updates to dashboard are done in a timely matter
  • Assist Quality System Supervisor with internal and supplier audits of the quality management systems. FDA, ISO, and other regulatory audits
  • Coordinate assignment of complaint evaluation with appropriate personnel.
  • Support and lead CAPAs and processes. This includes development of CAPA Review Board

Job Requirements

EDUCATION and/or EXPERIENCE:

This position requires an Associate’s degree (A.A.) from a two-year college or university; or two years’ related experience and or training; or equivalent combination of education and experience. Successfully completed ISO Internal Auditor training.

Preferred: Familiarity with ISO 13485:2003 and 21 CFR Part 820 as they pertain to this position.

COMPETENCY/SKILL REQUIREMENTS:

Excellent organizational skills, a high attention to detail, and ability to multitask.

  • Strong writing, grammar and proofreading abilities; can effectively present information in one-on-one and small groups and to other employees of the organization.
  • ISO Internal Auditor Training/Certification