Quality Assurance Specialist/ Manager Regulatory Affairs

Massachusetts Eye and Ear Infirmary - Boston, MA (30+ days ago)3.8

An experienced medical device quality professional to maintain a strong Quality systems that supports Boston Keratoprosthesis’s mission and core values.

Boston Keratoprosthesis is looking for an experienced medical device quality professional to maintain a strong Quality Systems that supports our mission and core values.
  • Maintains, and oversees a company-wide Integrated Quality System in accordance with applicable regulations and consensus standards such as 21 CFR820 QSR (and associated regulations and guidance), EN ISO 13485:2016, CMDR as well as Boston Keratoprosthesis Policies.
  • Supports and reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
  • Assists with international registrations
  • Assists with 510K FDA submission
  • Participates as the quality specialist within the company’s product development activities.
  • At least annually reviews the suitability and effectiveness of the quality system with executive management.
  • Responsible for Medical Device Reporting/Vigilance activities globally.
  • Interacts with all levels of management and cross functions.
  • Leads Change control and CAPA activities
  • Performs trend analysis on relevant data and takes appropriate action
  • Participates in the internal and external audit process, and oversees supplier management process
  • Maintains Risk Management Files and Complaint Files
  • Maintains Technical Files, Test reports of Product Conformity according to MDD 93/42/EEC
  • Participates in all FDA, ISO and Regulatory audit activities at Corporate.
Develops, implements, and maintains an effective, integrated, and compliant system for all QSR/MDD/CMDR requirements including but not limited to:
  • Document Management.
  • Monitoring and Trending.
  • CAPA.
  • Risk Management.
  • Quality Management/Planning.
  • Medical Device Reporting/Vigilance.
  • Supplier Management.
  • Systems Validation.
  • Process Validation (desired)
  • Employee Training
Other duties may be assigned.
Individuals need to have a “can do” attitude and be of a mindset that no job is too small or too large for them.
BS Degree is a must; Master Degree in Business desired
Strong knowledge of FDA, ISO13485, Canadian, and European medical device regulatory requirements and of standard quality assurance practices.
Minimum 2-5 years of experience establishing and maintaining quality systems in the medical device industry.
Experience in international marketing desired.
Professional quality discipline certifications (CQE, CQA, CQM, CBMA, IRCA-13485 Auditor or RAC) desired.