Quality Assurance and QMS Expert (Medical Devices)
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Quality Assurance and QMS ISO 13485 Expert
Location: Zurich / Zug
Role: Consultant, Subject Matter Expert
Team: Medical Devices
Role & Responsibilities
In your role as a Consultys Quality Assurance / QMS ISO 13485 Expert, you are supporting our local clients and team by:
Implementation and continuous improvement of the Quality Management System in order to ensure current regulatory requirements
Preparation and implementation of internal policies and SOPs
Handling of Change Control Requests, Non-Conformities and CAPAs, ensuring their adequate and timely closure
Support audit readiness (ISO 13485 and FDA 21 CFR 820)
Conducting internal audits (Self inspections and supplier audits)
Draft and negotiation of Quality Agreements
Review and formal approval of technical reports and/or batch records
Providing internal and external (QMS) trainings and coachings
University degree in Quality, Engineering, Sciences or another relevant discipline
At least 2-3 years in QA environment within Medical Device, Pharma or Biotech industry
Strong knowledge of European and US regulations, guidelines and standards such as ISO 13485, EC Directive 93/42/EEC, FDA 21CFR part 11, ISO 9001, ICH etc.
Broad working knowledge of QMS ISO 13485 regulations; basic understanding of medical device manufacturing process
Analytical and structured working style; strong attention to detail
Ability to effectively work as part of a multidisciplinary, international team
Fluency in English is required, German, French or Italian would be a plus
At a glance - Working as a Consultys Compliance Expert
Consultys is a LifeScience service company with diverse career opportunities. We link operational compliance, quality assurance, regulatory and own solutions in ways that master complex compliance challenges to help our Pharma, Medical Devices and BioTech clients in the regulated environment. Boost your career
A consultant position with Consultys boosts your career, as you benefit from interesting, hands-on compliance projects, internal and external trainings, 1:1 mentoring and the expertise of our passionate experts. Perks and Benefits
Consultys offers a wide range of benefits and opportunities for your professional development. Flat hierarchies, consulting with a partnership approach and a close-knit family atmosphere are essential elements of our company culture. Whether you join us as an intern, a recent graduate or a senior hire, Consultys offers great perks and benefits.
Take Action - Apply Now.
Please submit your online application in English or German language.
For further information, please contact our local Human Resources department.