Quality Assurance Supervisor
We are seeking a Quality Assurance Supervisor to join our Sligo site. As Quality Systems & Compliance Supervisor, you will report to the Site Quality Assurance Director and be responsible for maintaining the site quality system in compliance with all applicable quality system standards and regulations as well as company policies and procedures.
Core Responsibilities:
* Documenting and Establishing a Quality System
You will document and establish a quality system that 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.
* Liaison with Regulatory Authorities
You will liaison with Abbott Nutrition Quality Assurance and regulatory authorities bodies.
* Auditing the Quality System
You will audit the quality system with other management personnel when required.
* Product Quality
You will ensure that all manufactured products meet the requirements of regulatory authorities, end users, and Abbott.
* Quality Metrics
You will measure performance of the Quality System and provide metrics for management review meetings, monthly reports, etc., and at other frequencies as defined in relevant quality system procedures.
* Monitoring Quality Performance
You will monitor quality performance and advise management personnel on major quality issues.
* System Failures
You will ensure that management is kept informed of all system failures on a regular basis to ensure corrective or preventive action is undertaken where required.
* Training and Supervision
You will supervise and train relevant quality personnel.
* Product Non-Conformances
You will disposition product non-conformances.
* Change Control
You will review and approve change control/validation packages.
* Product Actions
You will coordinate product actions (recall, withdrawal, or stock recovery) from the marketplace, where required.
Supervisory/Management Responsibilities:
* Team Management
You will manage several direct reports in the Quality Department.
* Deputizing for the Site Quality Assurance Director
You will deputize for the Site Quality Assurance Director when required.
* Frequent Contacts
You will have frequent contacts with Abbott personnel at many levels, Division, Affiliate, and other plants.
* Closely Cooperating with Plant Personnel
You will closely cooperate with plant personnel at all levels.
EHS Responsibilities:
* Environmental Health & Safety Standards
You will ensure Environmental Health & Safety standards are met and all EHS regulations and procedures are adhered to.
* EHS Culture
You will foster an awareness of Environmental Health & Safety in the plant and promote a culture of continuous improvement.
* EHS Accountability
You will demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of Abbott's EHS Program.
* H&S Incidents
You will ensure employees report any work-related injuries or illness to employee health and are promptly investigated.
* EHS Training
You will attend EHS training assigned and ensure that employees who report to you attend required training.
* Investigating H&S Incidents
You will 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.
* Regular Staff Meetings
You will conduct staff meetings in which EHS is part of the agenda at least once per month.
Requirements:
* Degree in Quality Related Field
You must hold a diploma/degree in a quality-related, engineering, or business-related discipline.
* Regulated Manufacturing Experience
You must have a minimum of 6 years of relevant work experience, at least 2 of which in a regulated manufacturing environment.
* Team Management Experience
Previous experience in team management is a distinct advantage.
* ISO Standards Knowledge
You must have additional training or experience in quality systems standards ISO 13485 or ISO 9000.
* Communication Skills
You must have excellent communication skills.
* Team Building Skills
You must have strong team building skills.
* Flexibility and Innovation
You must be enthusiastic, energetic, and able to integrate quickly into a team environment.
* Medical Device Regulations Knowledge
You must have knowledge of Medical Device Regulations.