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- BBBH815198 May 09, 2022 Competitive
I have an excellent opportunity available for a QA manager responsible for the quality assurance function and driving a continuous improvement culture across the site.
In this role you will be predominantly responsible for contributing to the development and implementation of the QA strategy. This is a permanent role based in Dublin.
- Establish and develop quality systems, procedures, and policies in line with customer requirements.
- Lead the QA function to provide Quality oversight and drive standardization across the site for Customer Complaints, Validation & Qualification, Projects, Supplier Management, CAPA and Change Control.
- Lead continuous improvement initiatives around the quality systems processes with respect to compliance.
- Lead a high performing team towards metrics and KPIs.
- Liaise with customers to ensure complaints are communicated and effective corrective and preventive actions are implemented in a timely manner.
- Establish, monitor and reporting of Quality Key Performance Indicators both internally and externally.
- Lead and management of risk assessments across the business to drive quality improvements.
- Drive improvements on product and process and drive best practice across the business
- Lead the quality group in transfer projects to ensure transition into Operations
- Preparation, review, and approval of standard operating procedures and policies.
- Review and approvals of vendor qualifications and corrective & preventative actions.
- Planning and managing all activities with respect to quality audits / visits.
- Approval and execution of Validation Master Plans with follow through to Validation Summary Reports.
- Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
- Third level qualification in Engineering/Quality/Science with minimum 5 years' experience in quality management coming from a high-volume Medical Device or Pharmaceutical environment.
- Injection moulding experience desirable.
- Ideally will have experience of Medical Device development form concept to market launch.
- Knowledge and experience of Quality Systems/CFR's including ISO 9001, ISO 13485 and 21 CFR Part 21/820.
- Ability to lead and manage multi-functional teams.
- Must have a thorough understanding of statistics.
- 6 Sigma certified desirable.
If this role is of interest, please 'apply now'.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
Senior Consultant | Engineering Recruitment
+353 (0) 21 2300300