Excellent opportunity for an Experienced Quality Manager to join an International team and make tangible changes
Delighted to once again be working with a market leader who is passionate about its people, its products and puts Quality at the forefront of everything they do. This company has seen huge market growth in recent years and are on the look out for a highly experienced Quality Manager to join their Cork team. This role reports into the US and has 2 direct reports, one who is managed remotely. This role is all about communication, leading from the front and being able to manage, and exceed, stakeholder and customer expectations.
The successful individual will be responsible for creating a quality system for the importation of medical devices into the European Union. This includes achieving ISO 13485 certification, obtaining CE Marking for the product portfolio, and implementing the necessary quality check for the products to be imported. This individual will be the link between the Asian manufacturers and key customers for quality related issues, including factory audits.
- Create and maintain the necessary Quality System for importation of medical devices into the EU.
- Achieve ISO 13485 certification for the company and obtain CE Marking for their products.
- 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
- 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 and ISO 13485 standard requirements.
- 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.
- 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.
- 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.
Knowledge and Skills:
- Experience using an electronic Quality Management System (QMS) or QMS
- 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.
- Understanding of customs and beliefs of other groups or cultures.
- Excellent Organisational, problem solving skills and attention to detail.
- Ability to manage and direct the quality function team.
- 10 - 20% including international travel.
If you would like to hear more about this opportunity click the 'apply now' button below and I would be happy to set up a confidential meeting. Alternatively, call Kellie on 021 2300 300
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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