QA Specialist - Medical Devices job in Reykjavík, Iceland

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Good Manufacturing Practice (GMP)

Location: Iceland

This vacancy has now expired. Please see similar roles below...

An exciting opportunity has arisen for a QA Specialist to focus specifically on Medical Devices. The role based in Iceland is great chance to build your portfolio with a leading pharmaceutical company.

Job Responsibilities

Drive simplification & standardization of the QMS in line with overall quality strategies & initiatives
Establish international and regional /local relationships with RA, other QA Groups, Manufacturing, Development and Management
Ensure continuous regulatory knowledge as necessary for the business.
Host and manage site audits
Manage relationship with health authorities
Maintain oversight of customer feedback and post marketing activities (e.g. complaints, FSCAs, recalls)
Maintain oversight of supplier monitoring program
Perform internal and external audits
Maintain oversight of training program
Record and manage quality issues, escalating serious events to senior management
Lead Medical Device management review process and quality planning
Lead and/or participate in quality/compliance/regulatory projects

Skills and Requirements

Bachelor's Degree education in Pharmaceuticals, Law, Bioscience, Engineering or Business or equivalent field coupled with relevant business experience in Quality/Regulatory leadership roles.
5 years experienced working with EU, FDA, ISO 13485, ISO 14971 and other global Medical Device regulations
Strong collaboration skills and ability to build partnerships internally and externally
Experience of working directly with competent authorities
Change management experience and influencing skills
Track record of leading teams and driving results

To Apply

In case you have difficulty in applying or if you have any questions, please contact Katty Maia on +44 203 854 3317 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

#LI-KB1

#QualityAssurance