- Disposition of non-conforming material (NCMR).
- Lead and/or participate in product complaint investigations leading to root cause.
- Propose, lead, initiate, and follow up on Corrective Action and Preventive Actions (CAPA).
- Ensuring that all changes and associated documents are managed per internal and external standards, policies, and procedures.
- Ensuring the accuracy (Quality) of documents about numbering formatting, revisions, and content per approved changes.
- Incoming part inspection; ~ 70% Mechanical, 30% Electrical.
- In-process Inspection.
- HS diploma/GED.
- 2-5 yrs. combined experience of Document Control, Inspection, and/or Quality Assurance experience.
- Working knowledge of SAP PLM (1-2 yrs.).
- Proficient with MS WORD and EXCEL.
- Strong organizational skills, detail-oriented, and the ability to meet changing deadlines in a fast-moving environment.
- Ability to communicate effectively within a technical environment.
- Team player who is customer-driven.
- No travel required.
- Prior Medical Device/Biotech experience.
- Prior experience with a Document Control Platform such as Arena or Agile.
- Ability to work semi-independently within a regulated environment.
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Quality Assurance Specialist - Newton, United States - Cynet Systems
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Description
Job Description
Job DescriptionWe are looking for Quality Assurance Specialist for our client in Newton, MA
Job Title: Quality Assurance Specialist
Job Location: Newton, MA
Job Type: Contract
Job Description:
Pay Range: $27.29hr - $32.29hr
Preferred Knowledge, Skills, Education, and Experience: