Quality Systems and Compliance Supervisor

at  Collins McNicholas

Sector: Science & Pharma
Contact Email: sarah.flynn@collinsmcnicholas.ie
Job Ref: 22603
Our client, a global healthcare leader is keen to hire a Quality Systems and Compliance Supervisor. This an initial 12-month contract based in Sligo. 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.

• Documenting and establishing a Quality System which assures compliance with the requirements of I.S. EN ISO 13485, EC Directive (93/42/EEC), and internal corporate and international quality policies and procedures.
• Establishment of procedures and plans that define those elements necessary to meet regulatory, business and customer requirements.
• Liaison with internal Quality Assurance and regulatory authorities’ bodies.
• Monitoring quality performance and advising management personnel on major quality issues.
• Supervision and training of relevant quality personnel.
• Disposition of product non-conformances.
• Review and approval of change control / validation packages.
• 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.
• Ensure Environmental Health & Safety standards are met and all EHS regulations and procedures are adhered to.