Quality Manager Waterford
My client, an innovative and rapidly-growing medical device manufacturer in Waterford in the South East of Ireland, have a fantastic opportunity for an experienced Quality Manager to join their expanding teams in Jan/Feb 2021.
Reporting to the General Manager, as the Quality Manager you will ensure that the product is fit for purpose, consistent and meets both external and internal requirements including regulatory compliance, legal compliance and customer expectations.
- Manage a lead the quality team- Quality Engineering, Document control, Quality control inspectors
- Communicate and work closely with key stakeholders including Production, Planning and Engineering.
- Maintain a positive department attitude and ensure that all employees under your supervision are aligned with the company goals. Proactively, through the use of team meetings and other communication skills, develop sustainable goals and targets for each team within the area. Lead and develop team-Conduct Performance reviews
- Remain up to date with ISO requirements and ensure company is audit ready
- Plan and monitor internal audit schedule. Provide support to Regulatory and Customer audits
- Quality system development, implementation & maintenance
- Ensuring that processes meet with ISO and AS requirements.
- Assessing product specifications and customer requirements
- Monitoring performance by gathering data and producing reports.
- Supervising the programme of internal auditing and calibration.
- Managing quality issues to ensure timely and effective corrective actions to prevent re-occurrence
- Monitoring the ongoing performance and outputs of the quality process and providing updates to managers and directors around quality issues.
- Supplier and Customer Liaison on Quality Issues.
- Provide validation expertise to maintain validated status for the facility.
- Oversee the design and execution of commissioning and validation protocols on manufacturing equipment, software and process, and approve validation documentation.
- Maintain an understanding of cGMP regulations and guidance in relation to all aspects of qualification of process and equipment.
- Coordinate validation activities to ensure schedule adherence and compliance.
- Using statistical analysis, measure, control and improve on product and process robustness.
- Third level Qualification in Scientific/technical discipline
- 10+ years relevant quality leadership experience in a highly regulated manufacturing environment, medical device industry preferred
- Excellent people management and communication skills- Proven ability to lead, coach and develop teams
- Experience in Quality management, including quality systems management.
- Ability to introduce and embed new systems successfully with a thorough understanding of ISO 13485, AS 9001 and FDA regulations
- Experience in subcontract manufacturing with numerous product lines