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Quality Engineering Leader Validation & Change Control

Job Title: Quality Engineering Leader Validation & Change Control
Contract Type: Permanent
Location: Cork
Industry:
REF: 83556
Job Published: about 1 year ago

Job Description

Quality Engineering Leader ? Validation & Change Control
Our client, a global leader in the Medical Device industry, are looking to recruit a Quality Engineering Leader for their Validation & Change Control department for their Cork site.

Responsibilities:
  • Lead and manage the QA Validation team. The QA Validation team consists a technical team of engineers and specialists who will have responsibility for the Validation & Change Control processes across the Cork facility
  • Process owner for the Validation and Change Control processes
  • Ensure current processes are in compliance to applicable standards and regulations
  • Connect & build relationships across departments with functional leaders and other sites to understand existing expertise as well as opportunities to leverage skills and best practices
  • Engage with broader industry networks and forums on Validation & Change Control topics
  • Lead the QA Validation team in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with Process Changes, Product Transfers and/or New Product Introductions
  • Support the QA Validation team in developing and standardizing guidance for introduction and qualification of processes and equipment to the site
  • Ensure current processes are in compliance to applicable standards and regulations
  • Create an environment where opportunities for continuous improvement within the Validation & Change Control processes are identified, assessed and tracked to implementation
  • Provide support for Product Transfers and New Product Introductions. Ensure the appropriate Process Validation and Change Control expertise is deployed to successfully implement such projects in line with quality, timeline and cost commitments
  • Develop and implement a strategy for the Validation & Change Control group that aligns with the broader functional and site level strategic goals and priorities
  • Support and/or lead technical investigation into quality and compliance issues as required
  • Support and/or lead Problem Solving initiatives for medium to high complexity problems where scope may extend across the site
  • Member of the site Quality Leadership Team in managing Third Party / External Quality System audits or inspections
  • Support, lead and / or provide technical oversight and approval for Non-Conformance Investigations & CAPA.

Experience:
  • A minimum of a Bachelor Degree, preferably in Engineering, Science or a related technical field.
  • A minimum of 5-8 years? industrial experience, of which 3+ years in a supervisory role is required
  • Experience working a regulated environment is required. Such experience within a FDA / ISO 13485 regulated environment would be preferred
  • Experience of Process Validation in the Medical Devices industry is required
  • Demonstrated ability to successfully use, and coach others in the use of, recognized data analysis and problem solving methodologies is required (e.g. DMAIC, Six Sigma, etc.)
  • Strong coaching, mentoring and team development skills are required
  • Strong knowledge of Validation and Change Control Processes within the Medical Device Industry is required (including practical experience gained working in these processes)
  • Technical training and experience in using Statistical Techniques, Lean and/or Six Sigma methodologies is preferred (e.g. SPC, DOE, Reliability Analysis, etc.)


For further information on this Quality Engineering Leader ? Validation & Change Control in Cork please contact Nicola O?Connell on 091730022 / nicola@hero.ie
Check out all our open jobs on our HERO Recruitment website ? www.hero.ie

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