The point-of-care (POC) testing industry is changing faster than ever. At Abbott Point of Care, we’ve stayed ahead of the curve. We are a worldwide leader in fundamentally changing healthcare delivery at the point of care with solutions that are intuitive, innovative, reliable, and cost-effective for our customers.
Abbott Point of Care (APOC) has an opening for Sr. QA Auditor located in Princeton, NJ. The Auditor independently conducts assigned audits to assess compliance to applicable business/division requirements, external standards/regulations and Abbott Quality System requirements across multiple divisions or regions or has technical expertise. Participate in audits of manufacturing, supplier/Third Party Manufacturers and, commercial affiliate sites. Manages and or participates in initiatives/projects that are cross functional/ cross divisional in scope as Subject Matter Expert (e.g., due diligence, regulatory readiness, etc.) Seen as a technical expert, or demonstrates ability to perform cross-division audits. Ability to interpret and translate regulations into actions in a broad scope of activities across multiple divisions or regions.
**THIS ROLE MAY BE FILLED AT 1 LEVEL LOWER DEPENDING ON INDIVIDUAL RELEVANT SKILLS AND EXPERIENCE**
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
•Integrate regulatory, compliance, quality issues into audit and assessment planning processes, based on risk.
•Ensures compliance to Regulatory, Division, Site and Corporate policies and procedures by promptly reporting non-compliance issues.
•Understand technical decisions that affect product quality.
•Provide expertise audit support to the division in preparation for and during external audits
•Identify and communicate compliance issues and risks promptly so that they are understood.
•Identify compliance risks against current standards/regulations and may guide in the planning and execution of Quality System improvements.
•Provide guidance and trains colleagues, provides oversight to one or more junior level auditors.
•Utilizes expertise and audit intelligence during audits. Provides advice or recommendations for compliant and strategic solutions to complex quality issues.
•Understand the risk and benefits of findings on the division(s) through engagement with the businesses and/or regions.
•Demonstrates high proficiency in selected areas. For example: plastics and molding, IT and software quality assurance, good clinical practices.
•Researches and demonstrates understanding of global standards, regulations and regulatory bodies.
•Development of management and supervisory skills through execution of managerial responsibilities as needed.
•The position has broad responsibility that has significant impact across the corporation.
•Excellent written and verbal communication skills. Personal skills needed, which include tact, open-mindedness, maturity, tenacity, decisiveness and sound judgment.
Bachelor / University / College degree or equivalent in a technical area. Bachelor's degree is highly preferred.
Background and experience:
Minimum eight (8) years. Related experience in the IVD / medical device / related industry.
3 years minimum requiredauditing experience or equivalent.
Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820; ISO 13485; ISO14971; IVDR; MDR; etc.
Auditor Certification is a plus