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Quality Manager
Ref No.: 19-10760
Location: Cambridge, Massachusetts
Sunrise System Inc. is currently looking for Quality Manager in Cambridge, MA with one of our top client.
Job Title: Quality Manager
Job Id: 19-10760
Location: Cambridge, MA 02139
Duration: 4 months
Position Type: Hourly contract Position (W2 only)
 
Duties
  • The primary role will be to manage QA elements of Client's cGMP Quality System at the Cambridge facility.
  • As a member of the Cambridge Quality team, the person will work closely with Software
  • Development personnel and the Frankfurt Quality team in support of medical device development activities.
  • Essential job junctions with respect to the Cambridge facility include:
  • Managing the CAPA portfolio of projects to ensure these issues are being managed in a timely and compliant manner
  • Ensuring the effectiveness of the CAPA program at the site
  • Managing the Event portfolio to ensure Event closure in a timely and compliant manner
  • Leading or supporting root cause investigations
  • Managing the Cambridge Training Program
  • Providing support of site audits
  • Participating in the creation and updating of processes and work instructions
  • Daily QA activities and related cGMP compliance
  • Knowledge of FDA Regulations Part 11 and Part 820, ISO 13485, and IEC 62304
Skills
  • Experience in medical device, pharmaceutical/biopharmaceutical industry or related industry/cGMP environment.
  • Ability to work on strict deadlines. Ability to interface with cross-functional teams.
  • Detail oriented.
  • Working knowledge of the FDA Quality System Regulation.
  • Experience leading CAPA (Corrective and Preventive Action) activities.
  • Well-developed communication skills, both verbal and written.
  • Understanding of software engineering and development and experience in a relevant department has software as part of a medical device is a plus.
  • Understanding of software engineering and development and experience in a relevant department has software as part of a medical device is a plus. 
Education
  • Bachelor’s degree in engineering or technical discipline Skills and Experience: 
Required Skills
  • CAPA
  • DETAIL ORIENTED
  • QUALITY SYSTEM
  • CGMP
Additional Skills
  • MEDICAL DEVICE
  • AUDIT
  • BIOPHARMACEUTICAL
  • SOFTWARE DEVELOPMENT
  • TRAINING
  • FDA COMPLIANCE 
Contact
Pooja Sinha
Direct: (732) 272 - 0316 | Email: pooja.s@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com