Quality Assurance SupervisorLocations:
Ireland - Finisklin
Time Type:
Full time
Posted on:
Posted 30+ Days Ago
Job Requisition ID:
JOB DESCRIPTION:
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life.
Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.
Our 113,000 colleagues serve people in more than 160 countries. Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices, and nutritionals products. In Ireland, Abbott employs over 5,000 people across ten sites.
What type of work will you be doing?As Quality Systems & Compliance Supervisor, you will be reporting to the Site Quality Assurance Director with responsibility for maintaining the site quality system in compliance with all applicable quality system standards and regulations as well as Abbott policies and procedures.
Major ResponsibilitiesDocumenting and establishing a Quality System which assures compliance with the requirements of I.S. EN ISO 13485, EC Directive (93/42/EEC), and Abbott Corporate and International Quality Policies and Procedures.
Establishment of procedures and plans that define those elements necessary to meet regulatory, business, and customer requirements.
Ensure that quality procedures and instructions are understood, implemented, maintained, and accessible to the appropriate personnel.
Liaison with Abbott Nutrition Quality Assurance and regulatory authorities bodies.
Auditing the quality system with other management personnel, when required.
Ensure all manufactured products meet the requirements of regulatory authorities, end users, and Abbott.
Responsibility for measuring performance of the Quality System and providing metrics for management review meetings, monthly reports, etc.
Monitoring quality performance and advising management personnel on major quality issues.
Ensure management are kept informed of all system failures on a regular basis to ensure corrective or preventive action is undertaken where required.
Supervision and training of relevant quality personnel.
Disposition of product non-conformances.
Review and approval of change control/validation packages.
Coordination of product actions (recall, withdrawal, or stock recovery) from the marketplace, where required.
Supervisory/Management Responsibilities:
The position has responsibility for managing several direct reports in the Quality Department.
The position has responsibility for deputizing for the Site Quality Assurance Director when required.
EHS Responsibilities:
Ensure Environmental Health & Safety standards are met and all EHS regulations and procedures are adhered to.
Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of Abbott's EHS Program.
Ensure employees report any work-related injuries or illness to employee health and are promptly investigated.
Active participation and support of Abbott's EHS programs.
Attend EHS training assigned and ensure that employees who report to you attend required training.
Investigate all employee-related H&S incidents, spills, releases to the environment, and near misses, provide follow-up of corrective actions, and ensure close out.
Conduct staff meetings in which EHS is part of the agenda at least once per month.
Education and Knowledge Required:
Diploma/Degree in a Quality Related, Engineering or Business-related discipline.
A minimum of 6 years relevant work experience at least 2 of which in a regulated manufacturing environment.
Previous experience in Team Management a distinct advantage.
Additional training or experience in quality systems standards ISO 13485, or ISO 9000.Excellent communication skills.
Strong Team building skills.
Enthusiastic and energetic with the ability to integrate quickly into a team environment.
Demonstrated flexible and innovative approach to work.
Knowledge of Medical Device Regulations.
Accountability / ScopeThe position impacts directly on product quality and thus the financial and regulatory exposure of decisions could be significant.
The base pay for this position is:
N/
A
JOB FAMILY:
Operations Quality
DIVISION:
ANSC Nutrition Supply Chain
LOCATION:
Ireland > Sligo:
Carbury Point, Finisklin Industrial & Technology Park, Sligo
WORK SHIFT:
Ie - Ansl39S5 (Ireland)
TRAVEL:
No
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
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