Quality & Compliance Specialist

  • Location
    Blackpool, Lancashire
  • Category
    Chemical jobs
  • Contract Type
    Contractor
  • Shift Type
    Open
  • External Reference
    QCSP

Role: Quality & Compliance Specialist
Duration: 18 Month Contract
Location: Blackpool
Industry: Medical Equipment
Hourly Rate: Competitive

Summary of position
Part of the Quality Operations 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 on-going compliance with ISO13485, FDA QSRs and the Medical Devices Directive

Duties & Responsibilities (leadership, people development, planning and execution)
*Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.
*Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations.
*Manage & maintain Internal Audit schedule by agreeing annual requirements with QA Ops Compliance Manager & QS Manager
*Coach and guide Quality Operations / System and support staff as required to ensure appropriate control systems are in place and continually optimized to meet changing regulatory, corporate and industry standards
*Ensure all assigned quality actions, and all internal and external audit observations, are investigated, have causes identified actions plans completed, and appropriate effectiveness monitoring performed to the agreed schedule, regardless of source.
*Perform Internal Audits to schedule and complete audit reports and effectiveness reviews.
*Lead the external audit inspection readiness program for the site.
*Provide Front Room/ Back Room support during external audits
*Manage the response process for all external audit commitments. (From creation to closure)
*Implement harmonized MD&D Compliance Standards and SOPs
*Generate monthly and quarterly quality reports for review by senior and executive management, including the input to monthly dashboards, CAPA reviews and Operational or Executive Management Review meetings.

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
*Computer literate

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
*Computer literate

Education
*Minimum of degree.

Experience
*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.

Specific Technical Skills
Essential
*State specific type of skill required, e.g. must have experience of conducting validations

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

For immediate consideration please for the position now. Roevin acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. Roevin UK is an Equal Opportunities Employer.

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To speak to a recruitment expert please contact Shivraj Sisodia