Quality Systems Specialist

The Quality Systems Specialist is responsible for the development, structure, maintenance, and improvements of the Quality Management System.

Tasks:

· Lead identification, development, architecture, and optimizations of the Quality Management System, at both Global and Site levels.

· Work collaboratively and support process owners in reviewing, structuring, and documenting their functional new or improved processes.  Structure and integrate multi-referential in the same management system such as IT management system Business Continuity Management system, EHS, finance.

· Author procedures, policies, work instructions, and related documents with style, content, and format guidelines in compliance with ISO 13485, 21CFR820, EU MDR, MDSAP and other applicable regulations.

· Actively monitor effectiveness of the quality management system and propose and execute improvement projects.

· Lead complex quality initiatives (e.g. CAPA, process improvements, new processes, gap analyses, system integrations), make recommendations, develop and execute plans.

· Plan and conduct internal audits by participating and leading internal audits, follow up on the findings with auditee through effective closure, and present the data for trending.

· Support electronic QMS transition and take ownership of the software tools including QMS documentation and change control.

· Support Operational Quality with the handling of non-conformities, tool activities approvals, finish product release. 

Required abilities:

• Degree in Engineering, Scientific

• 5+ years of quality-related system experience in a medical device company developing medical devices

• Excellent technical writing, proofing, and language (grammar and spelling) skills with strict attention to details

• Significant knowledge of medical device Quality Management Systems (ISO 13485, 21 CFR 820) and regulatory landscape (i.e. MDR)

• Certified lead auditor for ISO 13485

• Knowledge in certification 27001 is a plus

• Excellent communication skills and interpersonal relationship skills

• Advanced problem-solving, organizational, analytical and critical thinking skills

• Electronic QMS experience is preferred

• Fluency in English is a must