J&J Family of Companies Director Quality Operations in Cork, Ireland
Position Title:Director Quality Operations
Reports to: DePuy Synthes Senior Director – Quality Operations
To provide quality assurance expertise and guidance to DePuy (Ireland) and DePuy International (Leeds) in line with established company and regulatory standards.
All Departments within DePuy (Ireland), DePuy International (Leeds), J&J Corporate Bodies, Notified Bodies and FDA during plant related activities, Equipment representatives and sub contractors.
Main duties and responsibilities
The site Director Quality Operations shall perform the role of Management Representative for DePuy Operations plant at Cork and DePuy Ireland (Global Supply Chain).
Responsible for Compliance and Quality System, and Microbiology/Sterilisation functions.
Participates as a key member of the facility management team for Cork plant.
Responsible for the recruitment, supervision, training and development of all QA personnel.
Establishes and maintains QS procedures and controls ensuring that performance and quality of the product conforms to established company and regulatory standards.
Maintains quality standards and procedures for processing materials into partially finished or finished material or product, including responsibility for calibration and metrology activities.
Ensures accurate maintenance of applicable device history and device master files.
Oversees the implementation and execution of inspections prior to the processing of raw materials/components, the monitoring of environmental conditions, the validation of all manufacturing and sterilisation processes, and the timely management reporting of internal/external quality results with conclusions for all required corrective actions.
Works closely with Operations at Cork and Leeds plants in a team based environment to insure process and product compliance with all relevant quality standards, including the formal certification of operations personnel to perform quality related inspection/audit activities.
Ensures new products are transferred into routine production effectively with all development documentation completed.
Conducts statistical analyses to assess the cost of, and determination of, the disposition of products or materials that do not meet standards and specifications.
Ensure active participation and support for all Health & Safety related activities.
Ensure that all Health & Safety requirements are fulfilled in accordance with the responsibilities defined in the Company Safety Statement.
To actively promote Health & Safety within the department and ensure Health & Safety is a goal for all direct reports.
Responsible for ensuring a systematic control of documents on the Cork site.
Ensure document control of all HSE procedures at the Cork site.
All employees are responsible for minimising both the environmental and health and safety effects of the work that they perform.
Establish and maintain QS procedures and controls to ensure that the quality and performance of the product conforms to specified company standards and comply with the recognised Regulatory Standards for all markets in which our products are sold.
Review and approve/reject all declarations of conformance for product under the control of DePuy (Ireland) as legal manufacturer.
Ensure audits are conducted in accordance with requirements of ISO 13485, FDA QSR 21 CFR Part 820 or other recognised regulatory standards for all markets in which our products are sold.
· Management Representative DePuy Cork manufacturing site and DePuy (Ireland).
· Review and investigation of complaints for product manufactured at Cork and Leeds plants.
· Quality System Activities within facility including agreed supplier audits.
· Resolution of Quality issues within Cork and Leeds facilities.
· Facility Operator Certification System and GMP training.
KEY COMPETENCIES REQUIRED:
· High Attention to Detail
· Pro-active approach to Work
· High Standards
· Excellent Communication Skills (written & oral)
· Influencing Skills
· Team Player
· High Level of Numeracy
· Highly Computer Literate
· Planner & Organiser
· Continuous Improvement Focus
QUALIFICATIONS & EXPERIENCE
· Degree level qualification or equivalent in an Engineering or Science Discipline.
· Minimum 5 years experience in a senior quality role within a regulated industry
· With a minimum of 10 years experience in a managerial position.
· ISO 9001 Lead Assessor qualification.
· Managerial experience working within an FDA and ISO 13485 regulated industry.
Depuy (Ireland) Limited (7386)