Reporting into the Quality Manager, the Quality Engineering Manager is responsible for the management of
the manufacturing quality function across the business and driving compliance and a “Continuous Improvement” culture
within West, Dublin The role is responsible for contributing to the development and implementation of the quality assurance strategy for West, Dublin.
- Must have a third level qualification in Engineering/Quality/Science.
- Must have a thorough understanding of Quality Systems / CFR’s eg. ISO 9001 / ISO 13485 / ISO 14001, 21 CFR Part 21 / 820.
- Must have a thorough understanding of statistics, SPC, and preferably DOE/Windows studies.
- Must have a minimum off >7 years quality management experience preferably in a high volume FDA regulated environment.
- Must be able to work in a team environment.
- Must be able to prioritize and organise tasks.
- Must have excellent communication skills both oral and written.
- Ideally will have experience of Medical Device development form concept to market launch.
- Ideally 6 Sigma certified “Greenbelt”.
- Ideally have injection moulding / high speed automation experience.
Essential Duties and Responsibilities:
- Establish and develop quality systems, procedures and policies in line with corporate and customer requirements.
- Directs the Operations Quality function to ensure all products are developed, manufactured, tested, stored and distributed in accordance with regulatory, customer and West standards, guidelines and procedures
- Lead continuous improvement initiatives to ‘challenge’ the quality systems processes with respect to compliance / value add.
- Lead and champion a quality/ patient first organisational culture that promotes behaviours that lead to superior quality and business performance and enterprise excellence.
- Coach, mentor and lead highly dynamic team members to help achieved the requirements of this position as well as the individual career goals of team members.
- Interface with customers to ensure concerns/complaints are communicated and effective corrective and preventive actions are implemented in a timely manner.
- Establish, monitor and periodic reporting of Quality Key Performance Indicators (KPI’s) both internally and to corporate including the coordination of necessary activities to drive improvements or address adverse trends.
- Drive the achievement of our set targets as specified in the ‘Balanced Score Card’ system of continuous improvement.
- Lead and management risk assessments across the business to drive quality improvements.
- Drive improvements via data analysis on product and process and drive best practice across the business
- Lead the quality group in transfer projects to ensure flawless transition into Operations
- Site subject matter expert on quality assurance plans and systems to ensure commercial manufacturing remain compliant with all applicable regulations and guidelines and customer expectations
- Preparation, review, and approval of standard operating procedures and policies.
- Review and approvals of vendor qualifications / corrective & preventative actions.
- Develop and implement strategy towards a business unit quality culture of ‘walk-in’ audit readiness.
- Chair, schedule and represent West at customer quality and technical meetings resulting in Quality Improvement Plans for each customer.
- Play an integral role in planning and managing all activities with respect to quality audits / visits.
- Approval and execution of Validation Master Plans (VMP) with follow through to Validation Summary Reports. This will also include the sign-off on validation documentation for operational validation activities.
·Responsible for the final disposition of product and for the decision on final batch release of medical device components, sub-assemblies and finished medical devices to West Customers and to the market.
- Drive and embed and preventive action culture via root cause investigation and collaboration with Operation’s.
- Interface with other West sites with respect to sharing of best practices.
- Act as a coach and mentor to reporting staff and colleagues.
- Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
- Compliance to all site Environmental, Health and Safety requirements, training and regulations.
- Compliance to all local site company policies, procedures and corporate policies.
- Perform additional duties at the request of the direct supervisor.
- Lead and manage a high performing team to deliver the defined business goals & objectives.
- Identification and development of talent to include performance management and succession planning (in the West Talent Gateway).
Delegation of Duties:
When absent from the site, duties and responsibilities will be delegated to the following designates
- QMS sign off eg CAPA / Deviations / Validation / Customer Complaints/ Change Controls/ Supplier Approval / Risk Assessments (QRM) / Audit Reports / Microbial Data / SOP / Product Quality Review etc.
- Quality Manager or Senior Quality Engineer
- Validation Documentation: VMP’s, Protocols and / or reports IQ / OQ / PQ/ Pre-PQ Checklists associated with NPI activities or change controls can be signed off by
- Quality Manager or Senior Quality Engineer for that relevant Customer
- HR Documents: Training reqs, Job Descriptions, Personal Adjustment forms etc..
- Quality Manager
- Purchase / Financial Documents: