Scientific Associate Medical Device and Combination Product Developer

QLS are recruiting for a Scientific Associate Medical Device and Combination Product Developer to join one of the European leading Biopharmaceutical Company on a contract basis until the end of December 2022, with a possibility of extension.

Headquartered in the Basel Area (Allschwil) in Switzerland - a European biotech hub – the company is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic area. This company has a broad portfolio of innovative drugs, an experienced team and a fully-functional research centre, the perfect combination that make this company a leader.

The Scientific Associate Medical Device and Combination Product Developer will have to guarantee the quality of medical device: parts, packaging and testing. He or She will have also to perform all internal Device functional tests (e.g. from early development to batch release as applicable) and maintain bench test equipment.

The Scientific Associate Medical Device and Combination Product Developer’s main responsibilities:

• Accountable and responsible for development of Device functional laboratory test methods, implementation and validation for design control, incoming control testing, clinical releasetesting and sound functional testing.
• Define, procure and qualify equipment required for the test methods in partnership with suppliers.
• Create validation protocols and reports in compliance with applicable procedures, write test method instructions and execute all qualification or validation
• Ensure compliance with all local, state, federal, and internal quality policies, procedures and practices, safety regulations, policies, and procedures.

Candidate’s Requirements:

• Degree in a chemistry, biology, biochemistry, pharmacy, or engineering field as well as sufficient work experience in a relevant field
• Previous experience in functional testing of medical devices/combination products
• Excellent skills in method validation and testing
• Knowledge of lab equipment, GLP, statistics and Medical Device ISO standard test method (ISO 11040, 11608…)

Apply: Please could you send any correspondence in English. For more information contact Kajenthi Chelliah at KChelliah@ckqls.ch or 0041 (0) 800 106106. Please quote job reference 54299 in all correspondence.