Quaility Engineering Manager

Recruiter
West Pharmaceutical Services
Employment Type
Permanent
Salary
Not disclosed
West Pharmaceutical Services logo

Summary: 

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.

Requirements:

  • 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:

Quality Manager