Collins McNicholas

Quality Systems / Quality Compliance Manager

The primary function of the Quality Systems / Quality Compliance Manager will be to;

  • Implement and ensure Quality System Compliance according to ISO 13485
  • Set direction and identify priorities of the Compliance to regulatory requirements. 

Responsibilities

Reporting to Plant Manager, you will be responsible for:

Leadership

  • Implement and ensures compliance to the quality requirements set in ISO 13485, GMP and corporate quality system.
  • Lead site personnel in the maintenance of compliance levels according to ISO13485
  • Leads the Documentation Control and Change Control processes
  • Leads Regulatory Affairs. Provide leadership and guidance in the implementation of regulatory strategies and plans to ensure currency of device Technical files and Design Dossiers
  • Lead the Validation process
  • Leads the Management Review process
  • Leads the internal audit and supplier quality processes
  • Leads the Sterilization process
  • Takes lead on assigned cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations.
  • Set direction and identify priorities of the compliance requirements
  • Assign resources and responsibilities.
  • Provide leadership and development of the organization to maximize effectiveness and assist development of employees of the Compliance and validation functions

Review & Evaluation

  • Implement and ensure compliance to the quality requirements per the site, GMP and corporate quality system ensuring all procedures and policies are up to date.
  • Integrates corporate requirements and promotes synergy/consistency with other sites.
  • Ensures a proactive evaluation of regulatory, compliance and quality issues and integrates them into the QMS on a priority basis.

Project Management

  • Responsible for leading continuous improvement projects including creation, scoping and implementation.
  • Participate as a key member of the departmental staff team contributing to the overall effectiveness of the business.
  • Project manage and schedule key projects and initiatives ensuring timely execution and goal achievement.
  • Implementation of lean manufacturing philosophy and six sigma principles to eliminate waste.

Communication

  • Represents company on corporate wide initiatives and teams as requested.
  • Report pre-defined KPI’s on a weekly basis and assist in developing the quality metrics.
  • Demonstrates through management style respect for the core values and a commitment to teamwork and communication.

Training

  • Trains employees on areas of expertise.
  • Develop the skills of the employees of the department, ensuring they are trained in all duties required.
  • Develop staff on new quality initiatives and assist in the understanding and rollout of quality initiatives across the department/site.

Requirements

  • A level 8 Degree in a Quality, Science or Engineering discipline
  • Excellent working knowledge of Quality System Requirements such as ISO 13485, MDSAP and 21 CFR 820.
  • 5 – 8 year’s experience working in the Quality Department of a Medical Device/Pharmaceutical or Healthcare company.
  • An understanding of SAP is an advantage
  • Organized with a proven ability to achieve targets.

For a confidential discussion and more information on the role, please contact Davin Ferguson on 071-9140251 or email davin.ferguson@collinsmcnicholas.ie

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