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.
- ESSENTIAL FUNCTIONS:
- 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.
- 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.
MINIMUM EDUCATION AND EXPERIENCE:
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.