Role: Quality Engineer
Location: Mullingar, Westmeath (On site)
Benefits: Good salary, pension, healthcare and yearly bonus.
Company:
My client are an exciting business located in a modern state of the art facility in Mullingar Co. Westmeath. Passionate about serving the world’s medical device and allied healthcare industries in offering a range of the highest quality innovative healthcare packaging solutions.
Role:
Reporting to the Senior Quality engineer and/or Quality and Regulatory Director the Quality Engineer will work in collaboration with the site team to champion & roll out the strategic initiatives which comply with the quality system requirement of ISO 13485 and ISO 11607 and in combination with customer request. To support our operation, engineering and R&D teams. The quality engineer will facilitate the development of new manufacturing process at the site and enhance the process and related quality system overtime. Customer onboarding and interaction is a significant element of the position.
Duties:
- Lead quality improvement programmes using recognised problem-solving and project. management techniques.
- 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. Customer onboarding process is a key element of the position.
- Management of customer documents into the Quality system i.e., Drawings; Purchase
- Specification; Quality Agreements etc. and the training of relevant personnel.
- Drafting and approving of quality documentation to meet Customer requirements i.e.,
- 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 e.g., Lean Projects.
- Co-ordinate activities associated with change management and customer interaction.
Experience required:
- Third level qualification in Engineering / Quality / Science.
- Two + years’ work experience in a Medical Device manufacturing environment.
- 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
- Ideally understand sterile sealing manufacturing process.
- An in-depth knowledge of validations and change control management in a Medical Device environment
Does this sound like your next career move? For more info forward your application or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie
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