Auditor, St Jude Medical - Plano, TX
Educate, advocate, and support QA and compliance operations ensuring that all applicable global Quality System laws, and regulations, together with business internal operating procedures, are identified, interpreted, communicated and applied without compromise by all concerned company employees and throughout the entire product development lifecycle.
Major, On-Going Responsibilities:
•Assist Audit Manager with development, management and execution of the NMD Audit program
•Establish and implement Master audit schedule with assistance and direction from Audit Manager
•Lead quality system audits to ensure the Global Quality Management System operates in a state of compliance
•Remain current on all regulatory environment changes and facilitate implementation to ensure compliance as required
•Develop and/or improve a system of metrics for the Audit program
•Complete, monitor, analyze, and present Audit data and trending to ensure quality system issues are identified, addressed and resolved
•Report to Audit Manager, potential systemic quality system issues through the analysis of quality data such as CAPAs, complaints, MDR, NCMR, Audit reports, etc
•Help interpret Regulatory requirements in a current regulatory environment and provide guidance and direction on the development, revision and/or maintenance of the quality system and business processes in compliance to applicable laws and regulations
•Verify and ensure compliance with the company's policies and procedures as well as Global Regulatory Requirements, such as FDA 21 CFR part 820, 803, 806, ISO 13485, AIMD, Canadian MDR, Brazil, Australia, Japanese regulations and other global regulations as appropriate.
•Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
•Identify Quality Audit Initiatives and lead cross-functional teams to complete them
•Communicate with Regulatory Agencies upon direction from management on compliance related issues, reporting, or activities
Experience & Training:
•Minimum 3 years relevant work experience with quality assurance, quality systems, or quality engineering in the regulated (FDA) industry
•Minimum 3 years experience in a medical device, pharmaceutical or biotechnology industry.
•Minimum 3 years experience with Audits or Quality systems.
•Minimum 3 years experience applying regulations (including FDA QSRs, ISO13485)
•Auditor certification required
•Ability to work independently in fast-paced environment with little supervision
•Ability to creatively problem solve to achieve effective resolution
•Ability to communicate effectively (both written and oral)
•Team-oriented and responsive to customer needs
•Strong problem solving and analytical skills
•Quality focused, attentive to detail and results oriented
•Ability to influence positive change effectively
•Ability to build strong relationships
•Proficient with software programs to facilitate data analysis work
•Knowledge of FDA CFR part 820, 803, 806 ISO 13485:2003, CMDCAS, AIMD, Japan Ministerial ordinances and other global quality system regulations
•Project Management experience a plus
•Strong attention to detail
•Influencing – champion initiatives that generate organization-wide understanding and support
•Problem Solving – establish resources, processes to gather information/data for problem solving or analysis
•Excellent communication skills, including written, verbal and interpersonal
•Decisiveness and judgment based on data and sound reasoning
•Ability to work independently with minimal supervision
•Takes initiative to perform tasks that benefit the organization