The primary responsibilities of this position are:
- Provision of on-going regulatory compliance, risk management, design control, quality systems and overall design assurance expertise and leadership to the EMEA Packaging & Labelling Design & Development Centre of Excellence team on an on-going basis.
- Provision of regulatory and quality systems leadership to the team as it transitions to Packaging & Labelling Design Ownership (Design Authority).
- Liaison with corporate, local and EMEA sites quality systems and regulatory affairs personnel to ensure team’s compliance and to drive alignment and harmonization.
- Monitoring of the release and updates to regulatory & quality standards, regulations and policies, execution of gap analysis, communication of changes to the team and driving compliance.
- Driving the implementation, maintenance and update of procedures that ensure packaging and labelling design controls are met.
- Creating and maintaining risk management documentation.
- Providing independent quality review for design reviews, project design plans, risk management, design validation protocols & reports for both design and development projects.
- Support the team in their design & development activities, carried out on behalf of other EMEA sites.
- Support the establishment of a Packaging Testing Laboratory in the Galway site.
- Support the integration of the team into the Galway site QMS.
- Provide direction for documentation Control, CMS (Change Management System) and CAPA processes.
- Manage communications with regulatory bodies such as BSI.
- Provide leadership in the preparation for and during audits. Take the lead and front the team’s participation in audits.
The ideal candidate will have:
- Demonstrated ability to deliver results, meet deadlines and expedite critical project completion.
- Strong technical capabilities.
- Strong people and communication skills.
- Proven ability to work well as part of a team and on own.
- Ability to lead virtual teams, including cross-site teams.
- Strong written and verbal communication skills, with ability to communicate effectively to multiple levels of the company.
- Bachelor’s degree / HETEC Level 8.
- A minimum of 5 years’ relevant experience in a Design Assurance - Quality Engineering field in a medical device or other FDA 21 CFR 820 or ISO 13485 regulated environment.
- Must have experience in the preparation for and participation in ISO audits.
- Experience in packaging and labelling design assurance very desirable.
- Qualified auditor to FDA 21 CFR 820 or ISO 13485 desirable.
- 10% - 15%