Balwinder Singh

Balwinder Singh has over 20 years of work experience in quality and compliance roles in the medical device industry. Balwinder started their career as a QA Tester at eBusiness Solutions in 2000 before moving to NDC/Cordis Corp as a QA Tech III in 2001. Balwinder then joined Cordis Corporation as a Senior Tech QA Systems in 2007 and worked there until 2012. Balwinder then worked as a Quality Tech at BSC/Stryker Corp from 2012 to 2013 before joining Acclarent Inc., a Johnson and Johnson company, as a Senior Specialist in Quality from 2013 to 2014. Balwinder also briefly worked as the Manager of Document Control at Procept BioRobotics in 2014.

Balwinder's longest tenure was at Xlumena Inc., acquired by Boston Scientific, where they worked as a Senior Quality Compliance Specialist from 2014 to 2016. In this role, they led various quality control functions including Document Control, Training, Record Management, MRB, and Internal Audit systems. Balwinder was also responsible for Supplier Audits, CAPAs, NCMRs, Complaints, and RMAs. Balwinder was involved in external and corporate inspections as well as the final product review and release. Balwinder played a crucial role in the successful transition of manufacturing activities to Galway, Ireland as part of Boston Scientific's acquisition. Balwinder received a prestigious team award for their contribution to the acquisition transition and also improved compliance by analyzing and implementing changes to the training system.

Balwinder's most recent experience was at Intarcia Therapeutics, Inc. where they served as a Design Control Specialist and QADC Specialist since 2016. In this position, they have been responsible for performing quality checks and data integration reviews of documents for NDA submissions. Balwinder also provided documentation during PAI and worked with the team to update the Design History File (DHF) and edit Design Control documentation.

Balwinder Singh attended Punjabi University where they pursued a Bachelor of Science degree. Balwinder'sfield of study included subjects such as Math, Chemistry, and Physics. In addition to their degree, they also obtained a certification in ISO 13485:2003 Lead Auditor from BSI in March 2015.