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Job Ref.: 1799

Job Title: Quality and Regulatory Manager – Medical Supplies – Dublin North – (Part-time position) – October 2019 - Urgent

Posted Date: 19/10/2019

Sector: Regulatory Affairs

Location: Ireland, Dublin North

Job Type: Permanent part-time

Job description:

Quality and Regulatory Manager – Medical Supplies – Dublin North – (Part-time position) – October 2019 - Urgent

Our client is a North Dublin based Irish Medical supplies company and is an ISO accredited supplier of medical products and equipment to all care centres. Their product range includes: sterile dressings, swabs, disinfectants, orthopaedics, endoscopy, CSSD and theatre supplies.

They are now looking to recruit a Quality and Regulatory Manager to join their team.

The position will be a part-time permanent position. The role is office based with the flexibility of working from home.

MAIN ROLE:

Management, Direction and Co-ordination of all quality and regulatory activities in the Company

RESPONSIBILITIES:

  • Maintain the Company’s Quality Management System
  • Adapt existing Procedures and documents that best meet the requirements of QS and the work-flow within the Company. Create new Standard Operating Procedures, as required
  • Review and approve and have overall responsibility for Risk Management documentation and processes, in conjunction with Product Development Manager, as per company procedures
  • Interact and support Product Development and other staff to facilitate efficient use of resources in compliance activities
  • Carry out training and communication activities with staff to ensure adequate understanding of Quality Systems and Regulatory requirements
  • Develop and execute a Quality Audit Plan
  • Ensure adequate and suitable equipment and process validation procedures are in place and being complied with
  • Provide quality oversight of validation (and appropriate re-validation) of equipment, processes and control

  • Coordinate, in conjunction with the Product Development Manager, the overall coordination of each new product’s design and introduction to production
  • Review and approve Design and Development documentation as per OncoMark Design and Development Procedures
  • Interact with Regulatory Bodies to provide information on requirements for Certifications and approvals
  • Administer the change control, deviation and CAPA systems
  • Update and implement, in conjunction with Product Development Manager, Health and Safety procedures and processes
  • Contribute to Senior Management team in the overall management of the Company

PRINCIPAL QUALIFICATION REQUIRED:

Bachelor’s Degree in an Engineering or Science Discipline

WORK EXPERIENCE:

  1. At least 3 years postgraduate experience in Quality environment with at least one years at supervisory/ management level, within a Medical Supplies/ evice Company.
  2. Excellent knowledge of an ISO 9001/2000 or ISO 13485 environment
  1. Experience in the preparation of Technical Documentation

  2. Experience in CAPA system management

KEY SKILLS:

  • Organisational and time management

  • Ability to work in a team

  • Problem solving

  • Team leader and motivational skills

  • Listening, writing and oral communication skills

  • Presentation skills

    PERSONAL ATTRIBUTES:

  • Highly self-motivated

  • Ability to work to deadlines and on own initiative

An excellent salary plus benefits package will be offered to the successful candidate.

For further information, please contact Paul Flanagan on Dublin or email your c/v in the strictest confidence to paul@pharmasolutions.ie asap

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