Job Description
This role involves leading the improvement and globalization of quality management systems in support of medical devices and combination products. We strive to have a significant impact on people's lives across several key therapeutic areas.
The Quality Manager is responsible for managing the sustainment, improvement, and globalization of the quality management system, providing compliance subject matter expertise to internal business partners, demonstrating quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland.
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 quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
* Conduct internal audits to assess the compliance of 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 medical device and combination products.
* Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions.
* Analyze and interpret quality system performance metrics, presenting to Management as part of Management Reviews.
* Program-manage initiatives intended to improve and globalize the quality management system.
Required Skills and Qualifications
Bachelor's 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 Certified Manager of Quality & Operational Excellence, Six Sigma Black Belt Certification, or Project Management Professional Certification.
Benefits
This is a hybrid role with 3 days on site, 2 days remote.
Others
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.