Occlutech is the leader in developing innovative products for the treatment of structural heart disease. The Company sells and markets ASD, PFO, PLD and PDA occluders, as well as a range of specialized occlusion devices and accessories in well over 60 markets around the world. Occlutech operates facilities in Germany, Turkey and Sweden. For additional information please visit our website at www.occlutech.com .
Clinical Quality Assurance (CQA) Officer, immediate opening REPORTS TO: Global Head RA/QA LOCATION: The successful candidate will be based in Germany (Cologne)

DESCRIPTION OF POSTION & RESPONSIBILITIES

Primary responsibilities of the CQA Officer include implementing and maintaining the Company’s Clinical Quality Assurance procedures, documentation and activities in accordance with the latest clinical and other applicable guidelines, standards and regulations. This includes supporting Clinical Research in its interactions with Competent Authorities (CA) or other local / international regulatory bodies, as well as other clinical trial-related Quality Assurance matters.

The CQA Officer is expected to closely with / her counter-parts at the Company’s sites, as well as with clinical, regulatory and R&D staff in Cologne, Jena, Istanbul and Sweden. Moderate travel to Jena or other Occlutech sites is required.

Responsibilities

Document / establish & maintain internal CQA and related regulatory documentation and processes
Implement and manage CQA improvement programs
Keep up to date with all related clinical-related legislation and compliance issues
Keep up to date with clinical guidance documents, international clinical standards, and/or consensus standards and interpret impact on CQA for guidance to Occlutech Staff
Manage and maintain CQA and quality systems databases
Prepare and assist Global Head or RA/QA in preparing annual reports and CQA trending reports
Work closely with the Company’s Clinical Trials department
Communicate any critical CQA or clinical compliance risks to Global Head or RA/QA
Support the Custom Made Device and Compassionate Use programs

Experiences / Skills:

Minimum 3 years of aggregate experience working in CQA and Clinical QM in the medical device industry with exposure to production-related QA work
Practical knowledge and training in GCP/GMP, ISO 13485 and ISO 14155
Knowledge of and experience in (clinical) regulations and guidelines pertaining to clinical trials in the medical device landscape
Clinical research knowledge
Hands-on working style
Excellent interpersonal and communication skills
Education level: University (BA/MSc)
Fluent English a must

Expectations:

Full employment (40 hours/week)
Office presence: in Cologne
Moderate travel to Jena or other Occlutech sites is required

APPLICATION PROCESS

Applicants must provide CVs & cover letters stating their interest in the position and their qualifications. Only CV’s and cover letters in English will be evaluated.

Occlutech GmbH Frau Katrin Biedermann Wildenbruchstraße 15 D-07745 Jena katrin.biedermann@occlutech.com Tel: 03641-675120 www.occlutech.com