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Senior Quality Compliance Specialist

  • Job reference: 924275
  • Location: Blackpool, Lancashire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 12/03/2019

OrionGroup are looking for a Senior Quality Compliance Specialist on behalf of our multinational medical devices client based in the Lancashire area on an initial 12 month contract.

Part of the Quality Operations Compliance (Quality & Compliance) team reporting into the Compliance Manager with a dotted line to the Quality Systems Manager. This role provides Compliance and Quality Systems support to the site. This includes the procedures and records required for the development of quality system processes in order to assure the ongoing compliance with ISO13485, FDA QSRs and the Medical Devices Directive

Job Specific Competencies

  • In depth knowledge of Good Manufacturing Practice
  • In depth knowledge of quality systems and techniques including ISO 13485 and FDA QSRs
  • ISO 13485 Lead auditor trained.
  • Knowledge of Quality toolbox including FMEA, Mind-Map, Root cause investigations

GLP Competencies

  • Ability to carry out structured problem solving decision making.
  • Ability to communicate effectively at all levels across the business.
  • Ability to build productive relationships at all levels of the organization.
  • Takes a determined approach to problem solving and to make informed decisions.
  • Ability to make complex issues simple.
  • Ability to manage and adapt to changes effectively.
  • Identifies ways of doing things better and faster.
  • Ability to listen effectively and remain open to other's ideas.
  • Ability to express opinions and ideas, verbally and in writing.

Education and Experience:

  • Minimum of degree.
  • Minimum of 3 years in an appropriate role in a regulated industry.
  • Well-developed organisational skills with an ability to work independently.
  • Working knowledge of ISO9001, ISO13485 and FDA Quality System Regulations an advantage.
  • State specific type of skill required, e.g. must have experience of conducting validations


  • Use of Microsoft Office suite including Project.
  • Lean Manufacturing application.
  • 6 Sigma Green or Black trained

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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