Job Title:QA MANAGER
Reports to:Senior Director of Quality Assurance & Compliance (Europe)
Location:Midlands - Ireland
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.
Under direct supervision of the Senior Director of Quality Assurance & Compliance (Europe) and with a dotted line to the Plant Manager
QA Staff in Company Location
4.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 Company Irish 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.
5.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.
a)Salary: €75,OOO to €90,000 depending on experience plus bonus
b)No. of Reports: 4 with a total team of 20
c)Healthcare: Cover extends to person, spouse & dependents with VHI
d) Pension Plan
Please forward CV immediately to:
For informal enquiries, please phone Christy O'Hara on 087-9473404 and if outside Ireland 00353 87 9473404