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Title:  Quality Engineering Manager

Requisition ID:  48532
Date:  Jun 17, 2022
Location: 

Dublin, Leinster, IE

Department:  Quality
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

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

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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