Quality Engineer (medical devices)

Role 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.

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 i.e. 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 i.e. Quality Specification Sheets (QSS), CAPAs, 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.
• 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. Ppks, Cpks, 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 companys 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.

Requirements:

• Must have a third level qualification in Engineering/Quality/Science.
• Must have 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 I s an advantage.
• Ideally have an understanding of plastic process manufacturing.
• Must have an in-depth knowledge of validations and change control management in a Medical Device environment
• Must have a working knowledge of statistics, SPC, and ideally the use of Minitab.
• Must have excellent communication skills both oral and written.
• 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.

For further details on this vacancy contact Katie at +353 1 2784671 or email your CV to kruddock@thornshaw.com. Log on to www.thornshaw.com for a full list of available vacancies. Thornshaw is a division of the CPL Group