As an expanding 30-year established Irish owned family company, we wish to appoint a Quality Manager as the Leader of our Quality operations, whose primary responsibility is to manage the day to day activities of our Quality Management System to the requirements of our Notified Body and Competent Authority Regulatory Requirements.
The combination role of Quality Operations Manager will encompass responsibility for the QMS functions across all departments. This hands-on role will involve leadership & key participation in all aspects of the daily quality and regulatory operations of the company.
Relevant Skills and Qualifications required for this position:
- A minimum of 3-5 years Quality Management experience, preferably in the Medical / Healthcare industry.
- A relevant third level Quality or Scientific related qualification.
- High degree of flexibility and leadership within a team environment.
- Strong leadership/team management skills and experience.
- Understanding of the Regulatory Requirements within the Healthcare Sector.
- Thorough working knowledge of ISO 13485-2016.
Management & Team Role Reporting
The Quality Operations Manager will report directly to the Managing Director for the weekly, monthly and quarterly key quality performance indicators for the successful management of our Quality Management System.
- Leadership of Quality Management team with setting of agendas and quality goals.
- Responsible for managing and maintaining Product Technical Files (Update as per evolving requirements).
- Review, registration and maintenance of new product files with notifying Body, Competent Authorities and other external markets.
- Oversee registration of products on the Competent Authority website.
- Ensure quality department targets and objectives are met.
- Approve all Standard Operating Procedures and ensure these are maintained and updated in the Q-Pulse Quality Management System.
- Lead all elements of Quality Control, document control, validation, Quality interfacing with other departments and supplier Quality assurance to comply with MDR.
- Overseeing the ISO13485 Quality Management System on a daily, weekly and quarterly basis.
- Site lead for Regulatory / internal audits.
- Preparing Reports for Quarterly management QMS review.
- Identification of Staff training requirements and keeping of training files in QMS.
- Provide advice and support to purchasing/ sales / customer service / technical personnel and other departments .
- Ensure all operations are fully compliant with SOP’s, policies, license details and are updated in accordance with regulations and directives.
- Reporting to senior management on all medical safety and quality issues.
- Work with fellow quality team to develop engagement of all employees in the improvement of Quality, creating training and quality standards to enhance and ensure competence in the Quality department.
Summary of Role of the Quality Operations Manager
The Quality Operations Manager role will be pivotal in building the company’s operational excellence across a diversified product portfolio for our growing international multi market company.
Salary & Benefits
Salary Negotiable and expected to be attractive & competitive for a senior management level position within the healthcare Industry with many benefits for the suitable candidate.