Sr Specialist Quality & Regulatory Compliance

Position Summary:

Develops practical and innovative ways to identify and meet short, mid-term goals and have the understanding and experience to execute business objectives. This position is structured to allow flexibility including remote work and on site when required.

This role can be locates in either the Salt Lake City, UT or Durham, NC areas requiring anticipated 50% onsite presence. 

Primary Responsibilities:

• Executes assigned quality projects, with guidance from Sr. Manager, using engineering principles, business standards, practices, procedures, and project requirements.
• Assures proper documentation of technical data generated for the assigned projects and/or tasks consistent with applicable quality directives and procedures.
• Documents quality systems and programs to ensure compliance with local / global regulatory requirements and corporate quality systems requirements.
• Participates in the following activities contributing to QMS compliance: CAPA (including analysis of data and trends in complaints, nonconforming materials and root cause analysis), change control, supplier quality, internal audits, quality training, QSMR, Risk Assessments, etc.
• Participates and communicates status, business issues, and significant developments in projects. 

Education/Skills/Experience:

• Bachelor’s degree with 4 years of experience in Quality Assurance or Quality Engineering. In lieu of a degree, a High School Diploma/GED with 7 years of experience also considered. 
  • Technical Writing (CAPAs, Deviations, Doc Control) experience preferred
  • ISO 13485 and /or 9001 experience highly preferred, with experience as a Lead Auditor desired
  • MDSAP experience preferred
  • Experience in Pharma or Medical Device industries preferred
  • CQA or CQE certification preferred 
• Competence in the selection and use of Quality Engineering Tools and Techniques.
• Requires computer skills including Microsoft Office Package (Excel, Word, etc.).

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