Quality Engineer

1 month ago

Cork, Ireland SGS Full time
Job Description

  • Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
  • Lead Investigation into quality related events.
  • Manage quality systems elements, including the non-conformance, CAPA, risk management, internal audits and document control
  • Supervise Quality Technicians
  • Ensure all process variables and their interactions are adequately defined.
  • Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s/ PCAs).
  • Drive and implement plant wide quality system improvements.
  • Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
  • Assist in the implementation of EUMDR requirements.
  • Provide expertise to various functions on quality related issues
  • Identify and implement appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
  • Approve change requests for product, process and quality system changes.
  • Define process, product and test method validation requirements, prepare and approve Master Validation Plans, protocols and reports approval.
  • Compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements).
  • Review of MRB trends and identification of appropriate corrective actions when required.
  • Develop, monitor, and report on trending metrics associated with the quality system.
  • Support the implementation of Lean Manufacturing across the site.
  • Transfer and implement product and processes from development or from another manufacturing facility.
  • Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
  • At all times, adopt a safe behavior by exercising due regard for the health and safety of yourself, colleagues, and clients, in line with the Company’s policies and procedures.
  • Ensure full compliance with the Company’s Code of Integrity & Professional Conduct, and always adopt behavior in accordance with SGS Equality & Diversity policy.

Qualifications

  • Minimum of Bachelor of Science Degree in Engineering/Technology.
  • A minimum of 3 years’ experience in a manufacturing environment
  • Experience in a QA environment (GMP is preferred).
  • Experience in the med device industry is desriable


Additional Information

 

  • Integrity
  • Strong analytical ability and associated problem solving
  • Excellent communication skills both verbal & written
  • Good time management & attention to detail
  • Results and performance driven
  • Compliance with SGS policies and procedures
  • Compliance with SGS and client  policies and procedures

​​​​​Along with an attractive compensation and benefits package including bonus, healthcare, pension and enhanced annual leave, We offer:

  • A friendly, supportive, approachable working environment with a down-to-earth culture
  • Continuous learning with the chance to expand and enrich your career with our dedicated training team
  • Career development opportunities across SGS

SGS is an equal opportunities employer.

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