Overview

MedAlliance, in partnership with Cordis, is a privately-owned medical technology company. It is headquartered in Switzerland, with offices in Germany, Singapore, UK and USA. MedAlliance has been dedicated to developing innovative drug-eluting balloons (DEBs) for patients suffering from life-threatening coronary and peripheral arterial disease. Using breakthrough proprietary technology, MedAlliance has found a unique solution to the challenge of controlled and sustained sirolimus release with SELUTION SLR™.

The Quality Control (QC) Technician is responsible for reviewing, inspecting, dispositioning, approving, and releasing raw material, labeling, and finished product lots. In addition, the Q.C. Technician will be assigned other duties as directed by the Q.C. Lead or by QA/QC Management.

Responsibilities

• Inspecting and disposition of raw materials and labels• Reviewing of work order documentation prior to product release• Preparing non-conformity documentation for material disposition as needed• Preparing release documentation and appropriate traceability labeling for incoming materials and product release• Providing Q.C. approvals of selected processes in the clean room manufacturing environment. • Completing other duties as assigned.

• Coordinating HPLC Testing with Q.A. Chemistry Team

• Pro-active review of Quality relevant procedures (SOPs, Q.I.s, RIRs, and Component Specifications

• Completing other duties as assigned.

Qualifications

• High School diploma or equivalent education, required.• Preferable 2 years of experience in a medical device or other regulated manufacturing industry, preferred.

• Attention to detail and focus allowing for the identification of discrepancies or anomalies• Basic understanding of good manufacturing and good documentation practices• Ability to read, comprehend and follow written procedures. • Ability to understand and follow verbal instructions.• Computer skills using Microsoft applications (Outlook, Word, Excel) and other computer software packages.• Fluent in English• Ability to communicate ideas, problems and solutions to quality lead or management.• Ability to collaborate in a team environment• Ability to work overtime and/or weekends, according to business need• Ability to be a back-up for second shift support, if needed