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OPEN POSITION

Quality Systems Engineer

Opportunity for an experienced Quality Systems Engineer to join Avenue as the business continues to grow, with responsibility for the overall management of the Quality Management System.

Avenue - a Nolato company based in Finisklin Business Park, Sligo is an award-winning mould-building company, and a growing medical device precision injection moulding business that has been successfully serving Ireland and the broader European markets for 30 years. Avenue also brings expertise in building ultra-high-cavitation tooling for the medical device, diagnostics, and pharmaceutical markets.

This position will provide Quality Support in the areas of Process Control, Procedural and System Audits, Document Change/ Control, CAPA’s & NC’s, Supplier Quality Management and incoming inspection and Training.  The Quality Systems Engineer will develop and implement continuous improvement initiatives and preventive measures to achieve quality targets and KPI’s. 

 

Responsibilities:

  • Ensures Quality Systems are implemented and continuously reviewed to ensure compliance with ISO9001 and ISO13485 Quality Management System. 
  • Understanding of customer documents i.e. drawings, purchase specifications, quality agreements etc.  
  • Manage and participate in the internal QMS Audit process- Ensure issues arising are communicated and action taken as appropriate.
  • Participate and interface in external audits (Customer, Corporate & Regulatory). 
  • Liaise directly with external auditors, customers and corporate on matters concerning quality and corrective/preventive action activities arising from product/ system non-compliance.
  • Develop collaborative relationships with all internal and external stakeholders and share best practices. 
  • Control and maintain the Supplier Quality Management System through supplier approval, auditing, incoming inspection, and performance monitoring activities.  
  • GMP, GDP & Induction Training.
  • QMS Documentation Control /Record Keeping.
  • Coordinate CAPA, NC and Change Control process to ensure timely resolution and closure of required actions. 
  • Prepare inputs for Management review and KPI’s.
  • Drive quality improvement programmes to achieve performance targets in areas such as audit compliance, reduced complaint levels, NCR and CAPAs, and recommend improvements to existing practices and processes.
  • Initiate product hold /containment actions, including completion of non-conforming reports. Generate and communicate Quality Alerts. 
  • Review & approval of process and equipment validation/ qualification.
  • Establish and support development of quality assurance strategies, processes, guidelines and control plans which assure quality and reliability of manufactured products.
  • Ensure risk management activities, including risk assessments and PFMEA’s, across the site are actively maintained and mitigated. 
  • Support the Quality & Regulatory Affairs Manager in meeting the relevant regulatory requirements. 
  • Perform miscellaneous duties as assigned by the Quality & Regulatory Affairs Manager.

 

Required Skills:

  • Degree in a Quality, Science or Engineering discipline.
  • Minimum of 4 years relevant experience in a Quality role essential, preferably in the Medical Device or Injection Moulding Industry.
  • Strong knowledge and application of quality system regulations and ISO standards, and able to support an environment that meets the quality goals of the company.
  • ISO13485:2016 Auditor training desirable with practical hands-on experience in QMS auditing. 
  • Experience of working with ISO 14001:2015 desirable.
  • Ability to manage multiple concurrent projects or activities, and able to prioritise effectively.
  • Excellent verbal & written communication skills, which include but are not limited to presentation, organisational and management skills.
  • Excellent attention to detail and problem-solving skills
  • Good knowledge of MS Office

Location

Sligo, Ireland

Apply by

December 09, 2022

Contact person

Sonya Connolly [email protected]