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Quality Assurance Engineer

Quality Assurance Engineer

Job description

Quality Engineer

A fantastic opportunity to join a rapidly expanding company in the med/tech industry.

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.

About Your New Role:

  • As a Quality Engineer, you will 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.
  • Manage quality projects in support of continuous improvement e.g., Lean Projects.
  • 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.
  • Interface with other departments daily.
  • Batch paperwork review and final decision to release product for shipment.
  • Complaints, and Internal/external quality results.

What Skills You Need 

  • Third level qualification in Engineering / Quality / Science.
  • 2+ 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
  • A working knowledge of statistics, SPC, and ideally the use of Minitab.
  • Auditing experience to the requirements of ISO 13485 / EU GMP / 21 CFR Part 820 is preferred.
  • Ideally have a working knowledge of Lean / 6 Sigma tools.

Core Role Competencies:

  • Excellent communication skills with internal and external customers, both oral and written.
  • Team player with strong work ethic
  • Strong written and verbal communication skills
  • Ability to manage, mentor and develop people within fast paced and flexible working environment.
  • Experience and/or ability to manage cross-functional team meetings, train, or coach other employees; and give presentations.
  • The ability to establish rapport with internal and external customers, peers, and employees in all departments.
  • Excellent organizational skills.