Site Director Quality AssuranceBased in Sligo, Ireland, we are looking to recruit a Site Quality Assurance Director to manage all aspects of Quality Control & Assurance, Quality Systems, Validation, Regulatory & Product Quality Assurance and reports to the DVP, Quality Operations, Abbott Nutrition Supply Chain. This person will ensure that the ANSC Plant meets its Customer, Division, Regulatory and Plant Quality requirements through the effective management of the Quality department.
Major ResponsibilitiesPromote awareness of the quality policy and education of personnel to support its intent.Operation of the site (manufacturing and pumps management) quality system ensuring compliance by all departments and personnel with the requirements of all relevant Quality, Regulatory and Compliance policies, procedures and directives.Promotion and awareness of regulatory and customer requirements.Establishment of procedures and plans that define those quality system elements necessary to meet regulatory, business and customer requirements.Management of outsourced processes to ensure conformity with Abbott quality policies and regulatory requirements.Ensuring that quality procedures and instructions are understood, implemented, maintained and accessible to the appropriate personnel.As management representative, report performance of key quality metrics and quality system effectiveness for management review.As PRRC for Quality aspects perform the requirements as outlined in the MDR Person responsible for regulatory compliance.Ensure that quality audits are conducted at sufficient frequency to assure compliance to, and effectiveness of quality systems and policies. (Includes outsourced processes).Ensure that products manufactured at Sligo meet requirements of end users, of regulatory
authorities and of the company.Liaison with Abbott Nutrition Division Quality Assurance and all regulatory bodies.Disposition of non-conforming finished product.Product lot withdrawal, and recalls, from the marketplace where necessary.Ensure management is kept informed of all system failures on a regular basis to ensure corrective or preventive action is taken where required.Supervisory/Management Responsibilities: The position has responsibility for managing several direct reports in the Quality Department, some of whom may have supervisory/managerial responsibilities.Additionally, the position will require a managerial role in the following areas:Frequent contacts with Abbott personnel at many levels,Division, Affiliate and other plants.Contact both in the field and in the plant with customers.Close contact with plant personnel at all levels.Contact with suppliers.Participation at Senior Management level in ANSC.Demonstrate Management competencies.EHS Responsibilities: Ensure Environmental Health & Safety standards are met and all EHS regulations and procedures are adhered to. Foster an awareness of Environmental Health & Safety in the plant and promote a culture of continuous improvement.Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of Abbott's EHS Program. Attend EHS training assigned and ensure that employees who report to you attend required training.Ensure employees report any work-related injuries or illness to employee health and are promptly investigated.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 Required:Bachelor's degree in a Science, Quality, or Engineering discipline; coupled with 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.It is a requirement that the person designated as PRRC (Person Responsible Regulatory Control) needs to have knowledge of and be certified to the Medical Device Regulations.Knowledge: Wide application of technical principles, practices, and procedures. Strong understanding of business unit.Previous experience in Team Management a distinct advantage.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.Accountability / Scope The position impacts on all plant quality, as well as manufacturing and the financial and regulatory exposure of decisions could be significant.The position has a wide scope for decision making within confines of agreed plant annual plan and updates. Activities broadly defined by agreed impact goals.Supervision is received through meetings and one on one meetings with Site Director and DVP, Quality Operations, ANSC. Periodic goal reviews, annual performance and career development reviews will also occur.
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