A Quality & Regulatory Manager is required by CareerWise Recruitment for our Shannon based client to lead the Quality & Regulatory Department, supporting the Design and Manufacture of a range of devices within a customer-facing medical device contract design and manufacturing organization. Reporting to the Company General Manager, with interaction with Company CEO, Executive Directors and Senior Management Team. Ownership of the ISO13485 / 21CFR 820 compliant Quality Management system, ensuring compliance to applicable standards and regulations; ensuring that the organization maintains all required EU, U.S. and International certifications; managing audits/inspections by U.S. or international agencies. Responsible for Quality oversight and driving successful completion of design & manufacturing project activity along with and coordination of activities to meet company goals.

THE ROLE:

• Provide leadership  in  the  implementation  of  the  company’s  quality  policies  and  foster  a  high- performance culture with quality right first time through our organization’s engineering design and manufacturing operations
• Develop quality strategy which aligns with Company business & growth objectives
• Day to day management of quality function.
• Leads customer facing quality discussions and implementation of quality plans and quality agreements for new customers and new projects.
• Participate and support internal and external audits.
• Guides internal team on industry best practices.
• Plan and grow quality team and function to meet future requirements in a growing organization.
• Monitor and  manage  CAPAs  and  customer  complaints,  taking  ownership  for  the  development, documentation and implementation of corrective actions
• Lead the  classification  and  investigation  of  non-conformances,  and  assignment  of  root  cause determinations and drive for timely resolutions
• Stays current with external and internal quality systems standards and requirements.
• Interfaces directly  with  Notified  Bodies,  and other regulatory  agencies  on matters  pertaining  to processes, products or Quality systems compliance.
• Overall Responsibility for Regulatory Compliance, acting as Management Representative for the Quality Management System

• Provides clear regulatory advice and guidance to the Company and where required to its customers, highlighting any updates to regulatory requirements
• Responsible for establishing and maintaining effective procedures for Quality and Risk Management processes.
• Develops and oversees all aspects of the Quality Systems to ensure compliance with standards, regulations and company needs and ensures employees receive adequate training and tools/equipment to assure their ability to perform assigned tasks.
• Provide overall  leadership  to  the  broader  team  and  other  functions,  and  foster  a  diverse, entrepreneurial environment that enable all participants to contribute to their fullest potential in pursuit of organizational goals and objectives
• Responsible for hiring, managing, developing and training Quality personnel as needed.
• Provide quality leadership for product development and manufacturing teams to ensure product safety, reliability, and quality through the effective use of planning, risk assessment, statistical methods, and process control during the design and manufacturing stages of the product life cycle
• Provide assistance and guidance to the Design and Development Team on all aspects of Design Control Documentation. FMEA, Quality Agreement, Quality Plan development.
• Ensure continuous improvement in product performance by incorporating learnings into new product development
• Provide direction to project teams and engineers in the processing and development of protocols, reports, procedures, deviations and change requests on a day-to-day basis for identified projects
• Plans, schedules, and completes projects in support of company goals and objectives.

SUPERVISORY RESPONSIBILITIES:

• Oversees all Quality Employees and consultant workload and deliverables.

SENIOR MANAGEMENT TEAM RESPONSIBILITIES:

• Develops effective  quality  metrics  (KPIs)  and  communicates  results  to  senior  management,  key stakeholders.
• Participates in Weekly & Monthly Senior Management Team meetings, and company Board Meetings as required, contributing to strategic initiatives relating to Quality and other General initiatives supporting company growth and development
• Provides strong integrity, vision, knowledge, and overall aptitude to the organization.
• Participates in customer and prospective customer meetings and demonstrations

REQUIREMENTS:

• Bachelor’s degree in Science, Engineering, Quality Management or related fields.  Master’s degree is preferred.
• Minimum of 8 years of experience in Medical Device industry.
• Experience working with Electromechanical based Class 2 medical devices an advantage.
• Experience and working knowledge of cleanroom and non-clean room manufacturing an advantage.
• Working knowledge of regulations and standards (e.g., 21CFR210, ISO 13485, MDD, MDR, etc.) with experience in executing Quality strategies.
• Lead Auditor qualification or considerable internal audit experience necessary.
• Strong understanding & practical implementation of statistical methods & reporting

SKILLS:

• Excellent communications skills.
• Ability to drive a culture of Quality Systems compliance and accountability
• Excellent analytical and decision-making skills
• Possess a flexible, pro-active approach to problem solving, be an adept negotiator and apply risk-based decisions.
• Ability to develop and maintain strong collaborative relationships with all functional departments of the organization along with the Customer and Supplier base.

Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. 

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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