Quality Assurance Specialist
Company: Midmark Corporation
Position: Quality Assurance Specialist
Location: Torrance, California
Posted: May 2, 2020
Job Type: Fulltime
Contact Name: Sandra Dancy
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
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.
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