Description
My client, a leading manufacturer of medical device products based in Co. Offaly, is currently recruiting for the role of QA Manager. The successful candidate will monitor the day to day QA Activities, set up and maintain a permanent improvement process of the QA Organization and of the Quality System, ensure the full compliance of QA activities with FDA, QSR, ISO 13485, Corporate Policies and other quality system requirements and be an active and effective part of the Management team of the site.Key Responsibilities
- Ensure that all aspects of the operational business in the site comply with cGMP legal and regulatory requirements as well as Group Quality Manual and Policies
- Provide direction, management support and leadership for QA/FDA remediation plans to insure compliance with FDA, QSR, ISO 13485, Corporate Policies and other quality system requirements.
- Ensure that compliance and quality risks are understood and are always an integral part of business decisions
- Support and supervise QA upgrade projects, harmonisation and ensure compliance with current standards
- Manage, support and supervise quality projects and ensure that quality problems and technical matters are resolved consistent with global standards
- Liaises with Operations, PD, and others dpts to prospectively plan QA support for project milestones
- Organize and conduct external Inspections (FDA, Corporate etc) and follow their remediation plan
- Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation
- Drive continuous improvement and efficiency initiatives in Quality operations
- Manage QA budgets
Minimum Qualification/Experience
- Masters Degree with 7-10 years experience or Bachelors degree with 15 years experience in the medical device or pharmaceutical industry, strong analytical skills, exceptional writing and interpersonal relationship skills.
- Demonstrated knowledge of UK, EU regulations, FDA regulations, ISO 9001, ISO 13485:2003, CMDR, Medical Device Directive Regulation (93/42EEC) and other National and International regulations and standards.
- General knowledge of statistical analysis.
- Strong Leadership skills with a tested and proven desire to motivate individuals and management team.
- Demonstrated planning excellence developing action items that lead toward the accomplishment of long term goals by balancing short and long term objectives.
If you feel you would be a good fit for this role please apply directly to this advert or contact Derek Sheridan on for further detail.
To find out more about Real please visit www.realstaffing.com