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Quality Specialist

  • Job reference: 927346
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 29/08/2019

Orion Group are looking for a Quality Specialist for our multinational medical devices client based in the East Cork area on an initial 6-month contract with the potential to extend.


Job Purpose
The primary responsibility will be in providing support to the existing Quality Specialist for a period of 6 months and will be Quality systems project based.

The focus of the projects will be to streamline and lean out existing quality systems while ensuring continued adherence to ISO13485 and 21 CFR part 820.
Main Responsibilities of the role

  • Assist with development of quality systems to assure alignment with current GMP/QSR, and ISO requirements
  • Takes a lead role in ensuring all processes in the quality management system are lean and efficient while continuing to meet FDA and EU regulatory requirements
  • These areas may include but not be limited to;

-Training

-Metric Management

-Supplier controls

-Audit management (internal & External)

-Change controls (internal and external)

-Document control (internal and External)

-Product certification process

-Receive and inspection

-Calibration systems

-Performs special projects and other related duties as assigned.

Desired Experience and Background of the successful candidate

  • A bachelor's degree in engineering or a related field and/or a combination of practical and educational experience in the medical device industry is required
  • Minimum of three (3) years' experience in Medical Device quality assurance with a background of working in a regulated manufacturing environment
  • Experience working in a quality specialist role in Medical Device
  • In depth knowledge of ISO13485 and 21 CFR part 820
  • Previous experience in ETQ and advantage
  • Experience in training systems, Change control management, CAPA management and document management in a regulated environment
  • ISO13485 lead auditor and internal auditor certifications an advantage
  • Demonstrated knowledge in FDA and ISO requirements including recent QSR experience
  • Participation in FDA & other Regulatory body's audits is desirable
  • Excellent written and verbal communication skills
  • Excellent interpersonal and organizational skills
  • Ability to work in a high-intensity, fast-paced environment
  • Creative thinking and ability/desire to think "outside of the box"
  • Team player


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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