Sr QA Auditor
Description de l'offre
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.
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
• Has the ability to interpret regulations and communicate clearly, both verbally and in writing, the finding and how it does not comply with the regulation
• Technically proficient and has the ability to understand when technical issues 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.
• 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 required auditing 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.
• 5 years minimum experience with 2 years' experience leading an audit
• Auditor Certification highly preferred
• Excellent written and verbal communication skills, which include the ability to clearly and accurately communicate findings
• Strong interpersonal skills needed (e.g., listening, negotiation, decision making, assertiveness)
• Ability to multi-task and work with a sense of urgency
JOB FAMILY:Operations Quality
DIVISION:APOC Point of Care
LOCATION:United States > Princeton : 400 College Road East
TRAVEL:Yes, 15 % of the Time
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf