Quality Systems Technician

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What you need to know

You will work as the Quality Systems Technician for our client, a highly successful and established medical device company in Co. Galway.

You will be a key member of the Quality team tasked with establishing, implementing and maintaining the Quality System on-site. You will work within the Quality Department reporting to the Quality Systems Engineer.

This is a permanent role.

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Key duties & responsibilities:

  • Support the Quality Systems Engineer in the maintenance and user training on the EQMS software.
  • Support the day to day running of the Quality Management System.
  • Gather and compile Quality KPI’s for Site Monthly Management and Corporate Management review meetings.
  • Coordinates the complaints handling process. Ensures that the files are audit ready and regulatory reporting requirements are met.
  • Coordinates the on-time closure of NCR’s, Planned Deviations and CAPA’s, supports maintaining audit-ready processes.
  • Issue, Evaluate & Disposition NCR’s throughout the facility.
  • Support Engineers in CAPA investigations. Liaise with various functions to identify the root cause of failures.
  • Support the maintenance of the Supplier Management System ensuring Supplier Evaluation & Qualification and on-going monitoring requirements are met and maintained.
  • Creates and issues SCAR’s and ensures issues are resolved and effective corrective actions are carried out.
  • Continually seeks to drive improvements in product and process quality Participate in six sigma / lean improvement projects.
  • Carry out area GMP/GDP audits and follow up on findings to ensure satisfactory closure.

What are we looking for?

  • An Engineering or Quality Assurance Degree or equivalent experience.
  • Possess an understanding of Quality Systems, is familiar with the Quality System Key processes.
  • An analytical approach to problem-solving.
  • Good computer skills.
  • A self-starter that applies their own initiative in most situations.
  • A good team player, who works well in a small dynamic team environment, must be able to work effectively with peers in other Departments.
  • A good communicator who can easily convey his/her ideas and requirements across all levels in the organization.
  • Capacity to make sound judgments while learning from mistakes.
  • Knowledge of the regulatory environment in which the business operates including FDA, European, Canadian, Japanese, and other International Regulatory requirements.
  • Attention to detail while maintaining awareness of longer-term objectives.
  • Strong interpersonal skills, a demonstrated ability to influence his/her peers and place quality at the forefront of everyone’s daily agenda.
  • Displays the highest levels of integrity.
  • Capacity to maintain the highest levels of confidentiality internally and externally.
  • Ability to stay connected to multiple projects simultaneously.

Desirable

  • Experience working with EQMS is a distinct advantage.

 

Apply for this job now or get in touch with Áine on 090 64 90485.

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Recruitment Consultant: Áine Clehane

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