Senior Quality Compliance Specialist

3 days ago

Minneapolis, Minnesota, United States Abbott Laboratories Full time
Job Title: Senior Quality Compliance Specialist

Join Abbott Laboratories, a global healthcare leader, in a challenging role that requires expertise in quality compliance and regulatory affairs. As a Senior Quality Compliance Specialist, you will play a critical role in ensuring the company's products meet the highest standards of quality and regulatory compliance.

Key Responsibilities:
  • Plan, perform, and document QMS compliance audits as certified lead auditor or team member.
  • Manage the tracking of the Audit CAPA corrective actions.
  • Develop and maintain internal audit checklists and tools.
  • Support internal and external team Sharepoint sites.
  • Maintain internal audit compliance files.
  • Follow up on internal and external audit observations and actions.
  • Update compliance team documents and procedures, as requested.
  • Support divisional quality and compliance initiatives, goals, and metrics.
  • Assist and support customer and external audits, as requested.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
Requirements:
  • Bachelor's Degree OR an equivalent combination of education or work experience.
  • Minimum 3 years Quality Assurance, Internal Auditing, Quality Compliance Management or related experience.
  • Minimum 5 years Medical Device/Pharma/regulated industry experience.
Preferred Qualifications:
  • Extensive experience on performing internal audits, managing external inspections/responses and be proficient in CAPA processes.
  • Experience working in a broader enterprise/cross-division business unit model.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Ability to multitask, prioritize and meet deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel approximately 15-20%, including internationally.
  • Any professional Quality System related certification (i.e. ASQ Quality Auditor, ASQ Quality Engineer, ASQ Biomedical Auditor, or equivalent).

Abbott Laboratories is an Equal Opportunity Employer, committed to employee diversity. If you are a motivated and experienced professional looking for a challenging role, apply now to join our team and contribute to the success of our company.

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