QMS Specialist Consultant # JN -072019-47689

Andover, MA

Posted: 07/10/2019 Industry: Business Analyst / Project Manager Job Number: JN -072019-47689
Job Functions:
  • The primary function of this role is to support document control and records management although other quality system elements may be supported (below) based upon candidate' s skillset
  • Review documents in preparation for release through the engineering change (EC) process and records for vaulting. Support audits/inspections as a scribe as appropriate
  • Must be responsive and customer service oriented with an extremely hands-on collaborative attitude. Must have typing abilities of 85+ words per minute to support scribing responsibilities
Other responsibilities may include:
  • Review gaps found in various Quality Management Systems such as Management Review and Internal Auditing. Providing support to the Quality System readiness project by assessing and reporting on gaps found in various Quality Management Systems such as Management Review and Internal Auditing
  • Additional support is being provided to work on CAPA actions needed to address non-conformances detected during various internal audits
  • Facilitate/execute document workflows, Identify and propose solutions to potential nonconformance(s), Manages document change requests for customers as needed, Review / edit user documents for compliance with current templates and procedures. Track and report status of documents/records in system, Support the documentation and management of changes
  • Support the revision and/or creation of department specific procedures and work instructions. Supports Quality Documentation Control system and its related processes, including coordinating the revision, review, and approval of SOPs and other documents and ensuring compliance with applicable standards and regulations
  • Activities includes, but is not limited to, document control function, including document login, tracking, processing, distributing, and archiving; processing QMS records such as events and CAPA, support the compilation of QS metrics; and participating in internal audits and supporting external audits

Experience / Education:
  • Minimum 4 years professional experience in the applicable role
  • Bachelor' s / Master' s Degree or equivalent. Demonstrated capability and experience in role
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