Manager, Medical Device and Combination Product Quality Systems
Manager, Medical Device and Combination Product Quality Systems
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Job Description
The Quality Manager is responsible for leading the sustainment improvement and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745 providing compliance subject matter expertise to internal business partners demonstrating AbbVie quality management system compliance to external regulators and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally this person will be based near one of our sites that manufacture medical devices in Ireland either in Sligo or Westport.
Responsibilities:
- Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative fulfilling all in-country obligations under EU MDR 2017/745.
- Host external audits in the EU region demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
- Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
- Lead root cause investigation and corrective action planning in response to external and internal audit observations in collaboration with departmental process owners and subject matter experts.
- Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
- Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions including Market Actions.
- Analyze and interpret quality system performance metrics presenting to Top Management as part of Management Reviews.
- Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications :
- Bachelors degree preferably in engineering physical science (e.g. Chemistry) life science (e.g. Microbiology or Biology) or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
- ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE) Six Sigma Black Belt Certification or Project Management Professional (PMP) Certification.
- Operates with a high degree of autonomy and accountability making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site 2 days remote.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
