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Quality Engineer

Requisition ID:  35437
Date:  Jul 17, 2021
Location: 

Dublin, Leinster, IE

Department:  Quality

 

 

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 to the Senior Quality Engineer within Operations this role ensures internal system compliance and customer specifications conformity. This role will ensure the timely and effective closure of internal/external quality issues.

             

Requirements:

  1. Must have a third level qualification in Engineering/Quality/Science.
  2. Must have 2+ years work experience in a Medical Device manufacturing environment.
  3. A working knowledge of quality systems such as ISO 13485 is essential.  Experience and knowledge of 21 CFR Part  820 and EU GMP is an advantage.
  4. Ideally have an understanding of plastic process manufacturing.
  5. Must have an in-depth knowledge of validations and change control management in a Medical Device environment
  6. Must have a working knowledge of statistics, SPC, and ideally the use of Minitab.
  7. Must have excellent communication skills both oral and written.
  8. Auditing experience to the requirements of ISO 13485 / EU GMP / 21 CFR Part 820 is preferred.
  9. Ideally have a working knowledge of Lean / 6 Sigma tools.
               
    Essential Duties and Responsibilities:
  • Interface on an ongoing basis with customers to ensure requirements / concerns/complaints are communicated and corrective and preventive actions are closed in a timely and effective manner.
  • Management of customer documents into the TGE Quality system ie Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel.
  • Drafting and approving of quality documentation to meet TGE and Customer requirements ie Quality Specification Sheets (QSS), CAPA’s, Defect Library etc.
  • Trending and track of quality data to support quality improvements across the business
  • Lead investigations into material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented. 
  • Adherence to incoming control requirements and supporting the SCAR process when required.
  • Participate in the review of validation protocols and reports to ensure quality compliance.
  • Executing internal process and system audits.
  • Manage quality projects in support of continuous improvement eg. Lean Projects.
  • Co-ordinate activities associated with change management and customer interaction.
  • Ensuring the timely and effective closure of day-to-day quality issues.
  • Interface with other departments on a daily basis.
  • Batch paperwork review and final decision to release product for shipment
  • Analysing and reporting of key measures eg. Ppk’s, Cpk’s, Cost of Quality, Customer Complaints, and Internal/external quality results.
  • Coach and drive a culture of compliance and continuous improvement.
  • 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.

 

Delegation of Duties:

[If required use bullet points to list the duties and specific responsibilities to be delegated]

 

When absent from the site duties and responsibilities will be delegated to the following designates

Senior Quality Engineer

 

 

 

 

 

 

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 kimberley.eby@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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