Quality Manager

Successful candidate will lead the development, maintenance, and execution of the quality management system to comply with ISO 13485 and 21 CFR 820 regulations.  Candidate will act as Management Rep in addition to overseeing CAPA, Document Control, Internal/Customer Auditing, Supplier Management, Training and Customer Complaint systems. Candidate must display strong organizational and communication skills and be able to function effectively in a fast paced environment.  Responsible for identifying, analyzing and developing improvements in productivity, quality, client relationships, and customer service.

Responsibilities Maintain QMS day to day operations (Doc Control, CAPA, Supplier Management, Training, Audits) Gather and present data for management review Champion continual improvement of system, ensure continued compliance with regulations Plan and integrate electronic QMS system Work with R&D, Manufacturing, QC, Supply Chain departments to assure quality Author new QMS documents Comply with Safety Guidelines (OSHA, NIH, MA DPH)

QualificationsBachelor’s Degree, preferably in life sciences Minimum 5 years QS/QA experience in medical device environment complying with ISO 9001/13485 and 21 CFR 820.  Prior start-up experience a plus. Clear, concise written and verbal communication ability Strong IT background with extensive experience in MS Office, QMS software  Candidates must be a US Citizen or Permanent Resident Green Card Holder. Local candidates preferred.

Commonwealth Sciences, Inc.

www.cwsciences.com