Quality Assurance Supervisor
Sligo
Permanent
Quality Assurance Supervisor
GxP Recruitment are thrilled to be supporting our Global Healthcare client who is a leader in providing enteral nutrition feeding devices, including enteral feeding pumps and pump sets. Enteral feeding (also known as tube feeding) is a means of providing nutrition to people who cannot obtain nutrition by swallowing. Enteral nutrition contains all the calories and vitamins a person needs.
What type of work will you be doing? What assignments, requirements, or skills will you be performing on a regular basis?
As Quality Assurance Supervisor , you will be reporting to the Site Quality 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
GxP Recruitment are thrilled to be supporting our Global Healthcare client who is a leader in providing enteral nutrition feeding devices, including enteral feeding pumps and pump sets. Enteral feeding (also known as tube feeding) is a means of providing nutrition to people who cannot obtain nutrition by swallowing. Enteral nutrition contains all the calories and vitamins a person needs.
What type of work will you be doing? What assignments, requirements, or skills will you be performing on a regular basis?
As Quality Assurance Supervisor , you will be reporting to the Site Quality 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 them requirements of I.S. EN ISO 13485, EC Directive (93/42/EEC), MDR (2017/745) 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 Quality Assurance and regulatory authorities bodies.
- Ensure all manufactured products meet the requirements of regulatory authorities and 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 of relevant quality personnel.
- Review and approval of change control / validation packages.
- Coordination of product actions (recall, withdrawal or stock recovery) from the marketplace, where required.
- Tracking and Trending of Pest activity for the site on a monthly basis and implementing corrective and preventive action when required.
- The position has responsibility for managing several direct reports in the Quality Department.
- Frequent contacts with personnel at many levels, Division, Affiliate and other plants.
- Close contact with plant personnel at all levels.
- Conduct staff meetings in which EHS is part of the agenda at least once per month.
- 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.
- 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.