Quality Manager
Firstaff Personnel
Dublin South
Quality Manager. Salary: €Neg DOE Permanent South Dublin / North Wicklow. Immediate start. Our client provides world-class manufacturing and logistics solutions to the medical device industry with many manufacturing facilities throughout Asia with additional logistics, customer support and design facilities in Europe and North America. Our customers are additionally supported by localised distribution close to their manufacturing locations. Our European operation was established as a direct result of our customers' requests to support the new product development processes and contribute in the initial stages of product design. Due to the continued expansion of the Irish division, we now have a requirement for a Quality Manager. Job Specification: The Quality Manager is responsible for providing quality assurance leadership in the management of suppliers to the Medical Device market. Responsible for providing supplier quality engineering support including managing supplier performance. The individual is responsible for leading project initiatives through project activities such as New Product Introduction, Qualification and Validation. Main Duties/Responsibilities: Provide support for the introduction of new components and component changes. Assume full responsibility for a product launch and/ or transfers from one of the strategic suppliers. Manage CAPA interface between supplier and customer – need to fully own this process! Drive out root cause and corrective actions associated with CAPAs. Lead the Quality System review from a Supplier Quality perspective. Engage with external customers/contacts include outside technical contractors, suppliers, consultants, second and third part auditors. Provides guidance to Purchasing/Logistics, Technical team and relevant stakeholders in applying supplier quality system requirements. Key Competencies Required: Excellent Communication Skills. Pro-active approach to work with hands on ability. Ability to interpret, communicate, and work from drawings and specifications. Flexible. Validation knowledge. Highly computer literate. GMP knowledge. High work standards. Customer focused. Qualifications & Experience: Essential: A minimum of a Bachelor's Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred. Minimum 5-6 years experience in a Quality or Engineering Function within a Medical Device company. Experience in the medical device, biotech and/or pharmaceutical industry is preferred. ISO regulations knowledge is required, ISO 13485 knowledge is preferred. Previous experience of product transfers/start up desired. Willingness to travel (8-10 long haul trips per year. Strong in root cause analysis skills. Strong communication, teamwork, and problem solving skills are required. Possess knowledge of statistical analysis tools (Minitab SAS preferred. Strong project/time management experience. Desirable: Lead Auditor Qualification. Process Excellence – Green/Black belt certification. Experienced in SPC, Product Validation and ISO 13485. Knowledge of component moulding products and manufacturing processes. *NB: All applicants CVS will be reviewed and should your skillset match our client's requirements, we will contact you via email / mobile. We are also happy to consider you for other open opportunities within Firstaff. If however, you object to us holding your data on file, please acknowledge via email by return. Please see our Privacy Policy below * Privacy Policy. Contact: Angela Dunne. Senior Recruitment Consultant. Firstaff Personnel Consultants. 85-86 Grafton Street. Dublin 2. Email:angelad@firstaff.ie. Tel: + 353 1 6797766. Web Page:https://www.firstaff.ie/engineering-jobs-dublin/ Linked In:https://ie.linkedin.com/pub/angela-dunne/10/159/115. This job originally appeared on RecruitIreland.com.
1989 days ago