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Senior Quality Engineer – ABWG

  • Pale Blue Dot® Recruitment
  • Galway

To apply for this job please visit palebluedotrecruitment.recruitee.com.

The Role 

As Senior Quality Engineer, you will work as part of a team to maintain high quality/performance standards across our clients company. Reporting to the Snr QE Lead, the position will be challenging and will require an ability to work autonomously.

 

Responsibilities

  •  Collaborate with the Project teams to facilitate the successful execution of the Design Services process and Commercialization of new products.
  • Provide expertise in the areas of Quality Assurance, Design Controls, Risk Management, Statistical Techniques, and Regulatory  Compliance and Submissions
  • Lead and Support Design Services engineering activities (including but not limited to)
    o New product introductions
    o Development and approval of new product documentation.
    o Qualification of new suppliers/ requalification of existing suppliers
    o dFMEA , Risk management activities
  • Provide expertise for new product introduction / product development / process changes with respect to:
    o Acceptance criteria development
    o Test method development/validation activities
    o Product / process validation protocol development and execution (IQ, OQ, PQ)
    o pFMEA , Risk management activities
  • Ensure that new medical device product development / new product introduction and changes to existing products are conducted in  Compliance with global regulations and internal procedures.
  • Participate in change review process for existing medical device products and new products under development.
  • Review Design History Files and Technical Files for conformance to applicable requirements.
  • Contribute to process improvement efforts by developing and updating procedures and work Instructions.
  • Develop and maintain documentation in compliance with FDA, ISO, MDD/MDR requirements
  • Provide on-going support to manufacturing site(s) for commercially available products
  • Process Customer Complaints and manage customer replies
  • Initiate / Approve Non-Conformance Reports & Lead Root Cause analysis investigations
  • Initiate / Support implementation of effective Corrective / Preventive Actions
  • Champion continuous improvement through CAPA system, handling of complaints, analysing key performance indicators etc.
  • Act as the QA representative for Supplier Quality management activities
  • Represent QA as part of the Material Review Board
  • Perform Internal and Supplier Audits
  • Support Notified Body / Regulatory Agency / Customer Audits
  • Review / Approve / Release final product documentation
  • Support the Environmental monitoring process and activities associated with Sterilization
  • Collate and trend Key performance indicator data
  • Actively participate in Management Review & Compliance meetings
  • Act as delegate for Quality Manager when required

 

Requirements

  • A degree in manufacturing engineering, quality engineering, life science or related field and a minimum of 5 yrs. experience within the Medical Device Industry at a senior level.
  • Proven record of handling multiple tasks simultaneously and ability to manage project timelines
  • Proven record of policy and procedure development
  • Can demonstrate understanding and application of quality philosophies, principles, systems, methods, Tools, and standards
  • Must be highly motivated with excellent communication skills and proven ability to work effectively as part of a team and interact Professionally with all organizational levels
  • Act as a mentor to less experienced colleagues
  • Quality Certification and Lead Auditor Certification is a plus
  • Supplier Quality engineering experience is a plus
  • Sterilization / Microbiology experience is a plus
  • Ability to travel is a requirement

 

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

Pale Blue Dot® Recruitment

“The Resource for the MedTech Workforce”

 

To apply for this job please visit palebluedotrecruitment.recruitee.com.