UK: +44 (0) 113 868 0522 | IRE: +353 (0) 76 680 3555 | CH: +41 (0) 76 824 7075 | AU: +61 (0) 2 4017 0272       info -at- explic8 -dot- com

Quality Management Specialist

Background

Explic8 is a boutique consultancy who specialise in specific sectors in the form of Value Streams

Life Sciences

  • Medical Devices
  • Combination Products
  • Pharmacovigilance and Drug Safety

Manufacturing and Supply Chain

  • Lean Manufacturing
  • 6-Sigma Process Management
  • Warehousing & Logistics
  • Global Networks Optimisations

Technology Partnerships (Digital Enablers)

  • MRPeasy, ERP Software Partnerships
  • KaizApp, Digital Enabler to Improve Continuous Improvement Sustainability

Our Need

Our growing company is hiring for a quality management specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.

Quality compliance specialist provides guidance and ensures compliance with ISO13485 & 9001, 21 CFR Part 820 and applicable good manufacturing practice regulations within our client companies.

Responsibilities for quality management specialist

  • Will monitor field progress, craft capabilities, proper installation techniques, good workmanship standards overseeing that all required NDT (non-destructive testing) per the specifications and standards is performed
  • The jobholder will support the implementation and monitoring of QRM program and initiatives
  • Coordinates the logistics around and conducts related audits of incidents, service requests and calls, including sample selection, documentation, and communication of results
  • Assists with the administration, collection, and analysis of customer-based surveys, including tabulation and reporting of the results
  • Records root cause, identifies and Known Errors and coordinates actions to fix the error
  • Adheres to and maintains high levels of expertise in all support processes, procedures, and quality expectations
  • Planning, establishment, coordination and follow-up on internal training courses related to the Q&E MS (induction, procedural training, regulations ) as classroom, eLearning session or similar
  • Preparation of training material and various presentations
  • Development and maintenance of setup for global KPI reporting on quality metrics
  • Data collection and trending

Qualifications for quality management specialist

  • Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485 / 14971
  • Two (2) year or more experience in the complaint handling, Medical Device industry, Customer relations, complaint trending, MDR submissions, FDA regulations, GMP and where applicable clinical and other laboratory functions
  • Successful working experience within a financial Shared Service Centre or in BPO (min)
  • Bachelor’s Degree preferably in an Engineering or Scientific discipline
  • Experience with software packages such as Business Warehouse, SAP, TrackWise, Crystal Reports, Minitab, preferred
  • Experience with statistical analysis and data presentation methods

Desired skills for Quality Compliance Specialist

  • FDA regulations
  • Excel
  • Good Documentation Practices as it relates to complaint filing
  • CDPH Regulatory and Licensing requirements
  • Federal and State Regulatory compliance
  • Medical terms and human anatomy
  • TJC standards
  • 21 CFR part 820 and Part 803 and ISO 13485 standard
  • CGMP regulations for US
  • MEDDEV Vigilance

Who Should Apply

We have an open policy of wanting to attract fresh young talent who have free thinking minds able to convert the various tools considering our business thinking.

The applicants should also have an understanding of business, in particular in the area of business performance improvement.

Contact Details

Telephone

+44 (0) 113 868 0522

E-mail

accounts@explic8.com

Apply now