QA Compliance Specialist (Medical Devices) - Intellectt INC

Job Description:
The QA Compliance Specialist position exists to support the execution of quality & regulatory functions in the organization to ensure compliance of the AV-SH quality/business systems to applicable regulations, standards and corporate policies. Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

• Support external audit activities (FDA, FDB, ISO registrar audits etc.).
• Audit areas of Abbott Vascular Quality System.
• Support administration of Quality System processes (CAPAs, Internal Audits etc.).
• Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports.
• Track and trend compliance activities on a periodic basis.
• This may include CAPA & IACA metrics etc.
• Generate compliance metrics for Management Reviews.
• Assist the organization to receive timely feedback on open corrective actions.
• Participate in cross divisional activities to integrate quality system information.
• Conduct review and update Quality System procedures as necessary.
• Assist in developing & conducting Quality System training as necessary.
• File Quality Records (audit reports, IACAs, CAPAs etc.).
• Ensure that all responsibilities are carried out in compliance with governing regulations and standards.
  

Duties:

• Heavy on the Administrative side
• Reading regulatory documents
• Understanding regulatory processes
• Reading through the changes
• Closing out regulatory changes
• Receiving publications
• Collaborate with quality experts to push risks
• Document impact
• Work in the quality systems
• Assist with write ups

Skills:

• Technical writing skills
• Understands global regulations (Latin America, Europe, Asia)
• Understands food nutrition
• Understands manufacturing
• Regulation or food policy
• CAPA is a plus
• Knows Office Suites

Education & Qualification:

• Bachelor degree in a Science related field. Preferred bachelor's in food science/Nutrition
• Bachelor Degree or equivalent plus 4 + years of related work experience or equivalent combination