Abbott Staff Auditor, Quality Systems in Plymouth, Minnesota
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
As a key member of the Reg Compliance team, ensure that Abbott CN Organization is in compliance with applicable Corporate, FDA and International Regulatory requirements. Perform assessments of Abbott CN quality systems to determine whether it is in compliance with the established requirements and to evaluate its effectiveness. Incumbent is responsible for CN Site/Business Unit/Affiliate Internal Audits as assigned.
- Audits all aspects of Abbott CN quality systems, as assigned. Must adhere to the Divisional Internal Audit schedule and deliver high quality reports on time.
- Develops audit plans including scope and objectives. Creates audit checklists based on assigned area, applicable regulations, and pertinent Abbott CN quality system/procedural requirements, and obtains approval from management 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 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.
- May supervise Abbott CN Internal Auditors as needed.
- May serve as escort to inspectors or assessors from regulatory agencies or notified bodies. Supports inspection readiness activities across CN sites and business units.
- 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.
- Analyses and present audit data for Quality Data Review and Quality Management Review meetings.
- Leads CN Internal Audit Program initiatives and supports Divisional Quality Systems projects as needed.
- Develops and provides training on cGMPs and Quality System procedures as needed.
Bachelor's degree or equivalent work experience 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.
Formal training to key regulatory requirements and/or external audit related certifications is preferred.
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.
(Influence/Leadership) 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.
(Planning/Organization) Must be very organized and have strong planning skills to work on routine and non-routine tasks.
(Cognitive Skills) 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.
Effective management of MS Office Applications - Word, Excel, Power Point.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com
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