JOB DESCRIPTION : Main Purpose of Role
Main Purpose of Role
As a key member of the Reg Compliance team, ensure that AV site is in compliance with applicable Corporate, FDA and International Regulatory requirements.
Perform assessments of Abbott Vascular quality system to determine whether it is in compliance with the established requirements and to evaluate its effectiveness.
Incumbent is responsible for the site Internal Audit Program.
Audits areas of the Abbott Vascular quality system, as assigned.
Develops audit plans including scope and objectives. Creates audit checklists based on assigned area, applicable regulations, and pertinent Abbott Vascular quality system / procedural requirements, and obtains approval from RC Manager as appropriate.
Evaluates the adequacy and compliance of systems, operations, and practices against regulations and site documentation.
Documents identified nonconformities and obtains concurrence with responsible management.
Communicates final results of audits to responsible management internally and elevates to Division as needed.
Tracks issues through to closure including reviewing the corrective action taken.
Oversees follow-up of corrective actions and audit closure, including escalating overdue or at risk items as necessary.
Responsible for the site Internal Audit Program. Must adhere to the Divisional Internal Audit schedule and deliver high quality reports on time.
May serve as escort to inspectors or assessors from regulatory agencies or notified bodies.
Serves as Subject Matter Expert in AV Quality System processes / procedures during internal / external audits and to other business units as requested.
Conducts and documents Corrective and Preventive (CAPA) investigations for any audit findings in area of responsibility or as assigned.
Approves CAPA investigations in the system as required per procedure or as needed.
Coordinates site Management / CAB Review meetings, including preparation of presentation materials and documentation of meeting minutes on a timely manner.
Supports site and Divisional Quality Systems projects as needed.
Develops and provides training on cGMPs and Quality System procedures as needed.
Supports Supplier Quality Engineering function by performing supplier audits as needed. Serves as Supplier Quality Engineer backup.
Bachelors Degree ( 16 years) in Engineering, Life Science or related discipline
A minimum of 8 years of related work experience in medical devices (preferably) or other FDA-regulated industry is required.
Incumbent must have extensive experience on performing internal audits, managing external inspections / responses and be proficient in CAPA processes.
Strong understanding of specified area (Technical / Business Knowledge).
Requires very strong leadership skills to positively influence others across departments and sites while conducting internal audits and defining / implementing required corrective / preventive actions.
Incumbent must establish an extensive network of support in the site and across the Division to facilitate the completion of assignments.
May participate in the development of less experienced staff providing guidance and offering counsel. May lead a project team.
Should be able to influence management on technical and / or business solutions. May interact with suppliers.
Must be very organized and have strong planning skills to work on routine and non-routine tasks.
Ability to work on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercise judgement within generally defined practices and policies and selecting methods and techniques for obtaining solutions.
Ability to work in diverse cross-functional team environment.
Excellent written and verbal communication skills.Detailed oriented.
Effective management of MS Office Applications - Word, Excel, Power Point.