Quality Assurance Manager - Medical Device
The Quality Assurance Manager will be responsible for importation of medical devices into the EU.
The QA Manager will also be the interface between the Asian manufacturers and key customers for quality related issues, including factory audits.
This position has 2 direct reports and reports into the VP of Quality based in the US.
- The Importation of medical devices into the EU.
- Ensures EU product and packaging specification meet EU and country specific directives
- Review all product technical specifications based on EU and country specific category directives
- Acts as the regulatory Responsible person must be in place for CE marked products and registered with the Competent Authority to ensure legal manufacture obligations are fulfilled. E.g. complaint handling post market surveillance, and Oversight of OEMs (Manufacturing sub-contractors) as legally required by regulations.
- Confirm all claims which can or must be used on package for each market and has responsibility for CE marking compliance
- Maintain QA documentation in accordance with cGMP (current Good Manufacturing Procedures) and ISO 13485 standard requirements.
- Act as the Management representative must be assigned for the ISO13485 QMS to maintain this.
- Overall responsibility for operations as outlined above.
- Manage the investigation of non-conformances and complaints, as requested by corporate headquarters and key customers; investigate non-conformances and complaints with vendors resulting in a reduction of future occurrences.
- Perform product inspections and in factory quality audits on occasion.
- Hosts any audits by the Irish Competent Authority and the Notified body
- Approve all procedures, specification and technical files that are needed for our products.
- Review and approve validation protocol and reports, study protocol and reports.
- Manage the change control system and initiate and implement change control procedures as required.
- Manage a variable workload to meet operational requirements.
- Ensure that all Health, Safety and Environmental requirements are fulfilled.
- Create & maintain a culture of total quality & continuous improvement throughout the organisation.
- Plan and manage the requirements and priorities of major objectives.
- Analysis and resolution of moderately complex management or technical problems.
- Operational responsibility for Legal reviews.
- Ensure a safe and productive workplace where legislative and commercial obligations are consistently met.
- Initiates/approves changes to systems, programs, products, policies to ensure consistency with company philosophy and culture.
- Approve functional division budget/operating costs.
- Bachelor's Degree in engineering/sciences (biology, chemistry, etc.) or equivalent experience.
- 10-12 years' experience in medical device quality assurance and FDA/EU regulatory. 5+ years managing people
- Experience using an electronic Quality Management System (QMS) or QMS software i.e. Master Control.
- Knowledge of European and FDA regulations, coupled with an understanding of relevant directives, standards, policies and guidelines and the ability to implement appropriately is also required.
- Strong communication skills with ability to communicate at all levels within the organization.
- Ability to work effectively with others to accomplish goals.
- Ability to explore options and make appropriate choices to support the business.
- Understanding of customs and beliefs of other groups or cultures.
- Excellent Organisational, problem solving skills and attention to detail.
- Self-motivated, results orientated individual.
- Leadership/ Management experience.
- Ability to manage and direct the quality function team.
- 10% - 20% Travel Max (1 Trip to US, 1 to Asia and 2-6 to UK/EU)
This is an excellent opportunity to join an established company as it expands its Irish operations. This is a permanent full-time opportunity and comes with excellent salary and full benefits package.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aidan Crowley at 021 4289605 or send your CV to email@example.com