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Senior Quality Engineer

  • Job reference: 924740
  • Location: Cork
  • Salary: Negotiable
  • Job type: Permanent
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 08/04/2019

Orion Group are recruiting for a Senior Quality Engineer on a permanent basis on behalf of our Multinational Medical Device Client based in the East Cork Area.

The primary responsibility is in providing Quality Engineering support to NPI (New Product Introduction), Operations, Engineering and Quality Management functions. Furthermore, you will lead the development of validations and change management initiatives in compliance with Medical Device Manufacturing Regulations and customer requirements. You will be required to interact with multiple Customer and company functional teams to achieve organizational objectives. You will have responsibility for supporting the product design and manufacturing through the application of Quality engineering skills also for multiple quality related projects and tasks, from product inception through product launch and process support.

Job Responsibilities:

  • Development of quality and operating systems, assure alignment with current GMP/QSR, and ISO requirements.
  • Manage Associate Quality Engineers and Quality Engineers as required.
  • Lead Audit backroom operations for external audits.
  • Participate in new product transfers and be responsible for the development of quality plans, verification of engineering tests and measurement practices using QA Tools.
  • Active participation in the review of engineering specifications to assure that quality assurance requirements are met and designs are successfully transferred into manufacturing.
  • Development of process controls using valid statistical techniques inclusive of SPC systems, sampling plans, correlation analysis etc.
  • Leadership role assuring activities in the area of equipment FDA and EU regulatory requirements.
  • Development of IQ/OQ, Process Validation test protocols and reports to support product development and manufacturing process changes in compliance with customer's control procedures.
  • Performs special projects and other related duties as assigned.

Skills, Abilities and Education

  • 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.
  • Preferred experience: minimum of three (3) years' experience in medical device quality assurance with a background of working in a regulated manufacturing environment.
  • Experienced in Process Validation to Medical Device Regulatory requirements.
  • Ability to develop and write protocols, validation reports, engineering reports, etc.
  • Experience in Project Management.
  • Working Knowledge in Analytical, Statistical techniques, SPC and inspection and test methodologies
  • Demonstrated knowledge in FDA and ISO requirements including recent QSR experience. Participation in FDA & other Regulatory bodies' audits is desirable.
  • Excellent written and verbal communication skills.
  • Excellent interpersonal and organizational skills working with the domestic and global sites and our customers.
  • 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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