Summary of Position:
This position is responsible for management of the quality assurance/quality systems functions with our client in Galway. This includes the quality engineering and document control functions. The Quality Manager also liaises with the Regulatory Affairs Manager to ensure that the company is compliant with all applicable regulations.
- Interface with other functions in a team environment providing Design Assurance, Regulatory Affairs and Quality systems input and leadership
- Represent the quality assurance functions on company product development efforts, and on review and approvals for quality system documentation.
- Build, improve and implement the company’s quality management system.
- Review and approve all company product labeling, including instructions for use.
- Review and approve all company product design and process changes and assess for impact to existing regulatory approvals.
- Develop design verification and validation plans, protocols, risk assessments and reports
- Actively participate in specification development in relation to design input development
- Provide guidance to team in the processing and development of protocols, reports, procedures, deviations and change requests on a day to day basis.
- Ensure use of applicable domestic and international standards and guidance documents in the company’s design, test and manufacture.
- Represent the company in all third party and external audits.
- Manage, as necessary, import/export approvals, device listings and facility registrations.
- Manage the quality assurance and quality engineering functions.
- Manage the document control function.
- Manage supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier’s methods, supplier audits, management of supplier corrective and preventative actions
- Serve as the company Management Representative.
- Ensure compliance with all company safety policies and procedures.
- Contribute to a positive and productive work environment.
- Effective communication skills, both oral and written.
- Diplomacy and negotiation skills with both internal and external individuals and organizations.
- Ability to work and collaborate with collaborate effectively with multiple internal disciplines, as well as external organizations to achieve company objectives.
- Ability to understand and interpret medical device regulations and apply them in a practical and consistent manner conducive to a start-up environment.
- Ability to understand technical concepts.
- Excellent attention to detail.
- Conduct that is ethical and advances the vision of the company and the quality of its products.
- Personal presentation that is professional and projects a positive image of the company.
- Professional discretion when disclosing and discussing information that may be confidential or proprietary to the company.
At least 10 years medical device experience for the following:
- Medical device industry experience.
- Cardiovascular experience in medical devices preferred.
- Creating, implementing and maintaining quality systems, in accordance with US (21 CFR Part 820) and European/International (e.g. ISO 13485) standards.
- Regulatory submission and approval experience for both market-release products and investigational products, in the United States, Europe, Asia-Pacific and other international markets is desirable
- Managing quality assurance functions.
- Knowledge of US and European medical device regulations, both pre-market and post-market desirable.
- Expert knowledge of medical device quality systems.
- Good understanding of medical device standards and guidance documents.
- Good understanding of human clinical study requirements for medical devices.
- Good understanding of statistical sampling requirements for medical devices.
- Good understanding of good documentation practices.
- Good understanding of quality inspection techniques, methods, sampling plans, etc.
- Good understanding of design controls, process validations, and risk management principles as they relate to medical devices.
- Bachelor’s degree required, preferably in a scientific or healthcare-related discipline.
- Advanced degree preferred.
This position manages individuals responsible for quality assurance, quality engineering and document control
The above statements are intended to describe the general nature of work being performed by individuals assigned to this job classification. They are not intended to be interpreted as an exhaustive list of all responsibilities, duties and skills required of the individual in this position.