Quality Assurance Specialist

1 day ago

Fermoy, Cork, Ireland beBeeQuality Full time €50,000 - €65,000
Quality Assurance Specialist

We are seeking a Quality Assurance Specialist to join our team in a shift-based position (12-hour shifts which include days and nights inclusive of weekends). A competitive basic salary + shift allowances and benefits package provided.

This role is perfect for someone who is passionate about quality and has excellent problem-solving skills. The successful candidate will be responsible for supporting quality process definition, setup, verification and improvements.

  • Key Responsibilities:
  • Support quality process definition, setup, verification and improvements.
  • Complete in-process testing on product.
  • Complete weekly leak & burst testing on product to ensure product is sealed correctly as per the required specification.
  • Verification of Critical process parameters (CPPs) & Line Clearance activities.
  • Conduct internal process audits to ensure conformance and effectiveness of the Quality System.
  • Support audits by demonstrating product testing requirements & best practices.
  • Feedback and improvement on customer 'Supplier Quality Issues.'
  • Prepare for and attend daily engagement process meetings.
  • Identify improvements through quality reviews and meetings on quality, yield, flow, documentation, control etc.
  • Escalation of quality issues where necessary & conduct non-conformance investigations when required.
  • Perform weekly environmental monitoring sampling of the ISO Class 8 Cleanrooms.
  • Prepare and review sterile release packs (Endotoxin & Bioburden test reports).
  • Conducting & verifying releasing of sterile product.
  • Support SMT line first-off verifications along with verifying line clearance activities.
  • Reviewing & approving unplanned maintenance activities when required across multiple assembly lines.
  • Determine lot suitability for release by reviewing production logs and final batch records against product specifications, procedures and electronic data systems.
  • Review and approval of Design History Records (DHR) by obtaining and verifying the contents of DHRs against the relevant documentation requirements.
  • Interacting with MES & Oracle Agile systems daily to ensure products are assembled as per the required specification.
  • Work space compliance to site requirements, ESD, MSD, housekeeping (5S), safety, etc.
  • Assure ongoing compliance with quality and industry regulatory requirements.

Personnel Specifications:

Essentials:

  • Minimum NFQ Level 6 Certificate / Diploma in Science or Engineering, or sufficient job-related experience.
  • Solid understanding and utilization of problem-solving techniques.
  • Proficient in the use of MS Word, Excel and PowerPoint.
  • Good communication and influencing skills.
  • Able to write standard operating procedures and training documents.

Desirable:

  • Experience in a similar quality role in the electronics manufacturing industry.
  • Experience in working within a medical device manufacturing environment.
  • Six Sigma Green or Black Belt certified.
  • Experience in New Product Introduction processes.
Benefits

The company offers a competitive salary, shift allowances and a benefits package. This role is suitable for someone who is flexible and willing to work a variety of shifts including days, nights and weekends.

This is an exciting opportunity to work with a reputable company and contribute to the success of their quality assurance team.

What We Offer

We offer a supportive and collaborative work environment, opportunities for professional development and a competitive remuneration package.

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