Telephone: 086 8395533
Quality Assurance Manager
Our client, a medical device company in Tullamore is currently looking to recruit a Quality Assurance Manager for their site.
Essential Duties and Responsibilities
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
- 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.
- Provides 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 integral part of business decisions.
- Establish and follow QA training program for the whole site.
- Support and supervise QA upgrade projects, harmonisation and ensure compliance with current standards.
- Implement a supplier QA program for the suppliers and sub-contractors associated with the products, including performing & co-ordination of supplier audits.
- 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 departments to prospectively plan QA support for project milestones.
- Organize and conduct external Inspections (FDA, Corporate) and follow their remediation plan.
- Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation.
- Proactive, analytical and predictive mind-set to
- Ensure timely and complete site reporting, including relevant KPI and indicators.
- Drive continuous improvement and efficiency initiatives in Quality operations.
- Carry out other tasks or responsibilities as directed, to continuously improve Quality Assurance within the Company.
- Manage QA budgets.
- Revision of existing product documentation as required.
- Create Technical Bulletins, Label designs and Product User guides as required.
Qualifications / Experience
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position:
- Minimum BSc, preferably Master’s Degree in a scientific or engineering discipline or equivalent with 8-10 years’ experience or more in the medical device or pharmaceutical industry, strong analytical skills, exceptional writing and interpersonal relationship skills.
- Demonstrated knowledge of EU regulations, FDA regulations, ISO 9001, ISO 13485:2003, CMDR, Medical Device Directive Regulation (93/42EEC) and other National and International regulations and standards.
- Demonstrate ability to increase value delivered by team through Performance management and successful challenging of underperformance.
- Strong project Management skills with a proven track record of successful execution of major programs
- Strong Leadership skills with a tested and proven desire to motivate individuals, and hold team members accountable for performance.
- Experience in Process Excellence tools is highly desirable.
The competencies identified below are general descriptions of the behaviour and underlying characteristics needed to successfully perform this role at the required level:
- Excellent communication skills (verbal and written) in particular clearly communicating any changes in corporate requirements and financial analysis and the ability to build and maintain relationships at all levels in the organization
- Demonstrated planning excellence, developing action items that lead toward the accomplishment of long term goals by balancing short and long term objectives.
- Problem Solving - takes an energetic and proactive approach to anticipating and preventing problems. Uses sound reasoning to arrive at conclusions and put permanent fixes in place.
- Attention to detail to ensure accuracy and consistency of key plant data.
- People Management – demonstrated ability to motivate team to achieve Plant goals and promote professional development.
For further information on this Quality Assurance Manager role in Galway please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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