JOB DESCRIPTION:
About
Our client 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 113,000 colleagues serve people in more than 160 countries.
We serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, we employs over 5,000 people across ten sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. We have commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
What type of work will you be doing? What assignments, requirements, or skills will you be performing on a regular basis?
As Quality Systems & Compliance Supervisor, you will be reporting to the Site Quality Assurance Director with responsibility for maintaining the site quality system in compliance with all applicable quality system standards and regulations as well as policies and procedures.
Major Responsibilities
- Documenting and establishing a Quality System which assures compliance with the requirements of I.S. EN ISO 13485, EC Directive (93/42/EEC), and Corporate and International Quality Policies and Procedures.
- Establishment of procedures and plans that define those elements necessary to meet regulatory, business and customer requirements.
- Ensure that quality procedures and instructions are understood, implemented, maintained and accessible to the appropriate personnel.
- Liaison with our Nutrition Quality Assurance and regulatory authorities bodies.
- Auditing the quality system with other management personnel, when required.
- Ensure all manufactured products meet the requirements of regulatory authorities, end users
- Responsibility for measuring performance of the Quality System and providing metrics for management review meetings, monthly reports etc and at other frequencies as defined in relevant quality system procedures.
- Monitoring quality performance and advising management personnel on major quality issues
- Ensure management are kept informed of all system failures on a regular basis to ensure corrective or preventive action is undertaken where required.
- Supervision and training of relevant quality personnel.
- Disposition of product non-conformances.
- Review and approval of change control / validation packages.
- Coordination of product actions (recall, withdrawal or stock recovery) from the marketplace, where required.
Supervisory/Management Responsibilities:
- The position has responsibility for managing several direct reports in the Quality Department.
- The position has responsibility for deputizing for the Site Quality Assurance Director when required.
EHS Responsibilities:
- Ensure Environmental Health & Safety standards are met and all EHS regulations and procedures are adhered to. Foster an awareness of Environmental Health & Safety in the plant and promote a culture of continuous improvement.
- Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of our EHS Program
- Ensure employees report any work related injuries or illness to employee health and are promptly investigated
- Active participation and support of our EHS programs
- Attend EHS training assigned and ensure that employees who report to you attend required training
- Investigate all employee related H&S incidents, spills, releases to the environment and near misses, provide follow-up of corrective actions and ensure close out
- Conduct staff meetings in which EHS is part of the agenda at least once per month.
Education and Knowledge Required:
- Diploma / Degree in a Quality Related, Engineering or Business-related discipline.
- A minimum of 6 years relevant work experience at least 2 of which in a regulated manufacturing environment.
- Previous experience in Team Management a distinct advantage.
- Additional training or experience in quality systems standards ISO 13485, or ISO 9000.
- Excellent communication skills.
- Strong Team building skills.
- Enthusiastic and energetic with the ability to integrate quickly into a team environment.
- Demonstrated flexible and innovative approach to work.
- Knowledge of Medical Device Regulations.
