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Quality Manager – MIDLANDS – Permanent.
Growing medical devices organisation seeking to expand their Quality Team !
Reporting to the Senior EU Director of Quality your core responsiblities include:
– Assures quality products and processes, and Quality Standard Compliance by establishing, enforcing and maintaining quality MAP and compliant QMS.
– Establishes and maintains a permanent improvement process of the QA Organization and of the Quality System.
– Ensures the full compliance of QA activities with FDA, QSR, ISO 13485, Corporate Policies and other quality system requirements.
– Management of QA staff, and be the Management Quality representative inside and outside the plant (Competent Authorities / Notified Bodies, etc). Be an active and effective part of the Management team of the Site.
– Lead Ireland based QA Team.
- 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 Ireland 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.
For a confidential discussion and more information on the role, please contact Mary Mullin on 09064 78104 and email your cv to email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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