Director, Quality Assurance BG Medicine

BG Medicine, Inc. is seeking an experienced Quality professional to lead our Quality Assurance group in an FDA Quality System Regulation (QSR) and ISO 13485:2003 compliant environment for In Vitro Diagnostics. The candidate will provide expertise and leadership in all quality aspects of commercial products. This includes oversight of all CMO functions, all internal Quality responsibilities, and participation in Design Control and Product Development projects. The successful candidate will have the ability to proactively identify and interpret compliance risks, and to resolve complex problems with exceptional functional and technical skills.

Primary Responsibilities:

Lead all Quality Assurance activities for BGMs commercial diagnostic (IVD) business, including internal audits, vendor qualifications, document control, CAPA and training
Consistently apply an extensive technically diverse knowledge base in the decision making process
Ensure compliant, robust, efficient, and sustainable quality systems are in place to support quality department requirements and business processes
Represent Quality Assurance on product development teams; provide guidance and direction on design control requirements, risk management, testing standards and regulatory requirements


Qualifications:

Minimum 15 years experience in the FDA-regulated field, preferably medical devices or IVDs
B.S./B.A. in Biology, Chemistry, Engineering, or related field
Excellent written and verbal communication skills to work in interdisciplinary teams
Strong working knowledge of applicable FDA regulations and ISO requirements
Strong knowledge of Microsoft Office

Location:	610 North Lincoln Street Waltham, MA 02451 United States