Sr. Design Assurance Specialist

Primary Duties & Responsibilities:

Design Assurance

• Consults to ensure that high quality products are designed and manufactured by BMT. May provide expertise, training and/or consulting in Quality processes and methods to build and maintain a quality-oriented culture.
• Contributes to the generation and upkeep of risk management documentation as part of product development projects.
• Performs periodic updates to product risk management documents. This may include but not limited to analysis of complaint data, PSURs, risk management plan/reports, FMEAs, BRAs, and PHSRs.
• Coordinate interactions between design assurance and the medical advisory board.
• Develop and implement improvements to quality system processes. This may include actions resulting from CAPAs, quality plans, or audit findings.
• Develop and maintain product knowledge of existing and new products.
• Participate on project teams (product development, sustaining, and sourced finished medical device) and completing items as assigned.

Post-Market Surveillance

• Provide support for the Annual Global Post-Market Surveillance Reports
• Provide Global Complaint Data for input to Annual Clinical Evaluation reports, Annual Risk Reports, Health Risk Assessments, Failure Modes Effects Analysis (FMEA), Fault Tree Analysis
• Partnering with Post-Market Surveillance to incorporate products into the Post-Market Surveillance complaint database.
• Perform data analysis and data reporting limited/full market release product surveillance and other data requests as needed (Clinical, Regulatory Affairs, R&D).
• Partners with cross-functional teams to fulfill global Post-Market Surveillance, Clinical Evaluation, and Risk Management reporting requirements.

Does this position have supervisory authority? Yes No

Qualifications (Knowledge, Skills & Abilities):

Minimum

• BA or BS degree, or a combination of education and medical device experience providing equivalent knowledge
• 5 years medical device industry experience
• 3 years Quality experience in the medical device industry
• Working knowledge and experience with ISO 13485, 21CFR 820, and EU Medical Device Regulation
• Familiarity with 21 CFR 803 Medical Device Reporting and ISO 14971 Risk Management.
• Must have excellent verbal and written communication skills, initiative, flexibility, creative thinking and the ability to understand the underlying technical principles of ACIST products
• Must also have the ability to work with individuals at all levels of the corporation in a congenial and cooperative manner
• Experience working on cross-functional teams
• Ability to develop clear, concise, and timely oral and written reports.
• Must have organized and effective work habits.
• Proficient personal computer skills including Microsoft Office, database activity, word processing, spreadsheet, graphics, etc.

Preferred:

• Experience with minimally invasive medical devices
• Experience with TrackWise, Agile, SAP or other validated software used in quality management systems
• Experience working with post-market complaint data, risk management records, and risk management reports

Other:

• Mental demands - work is detail oriented, often with multiple priorities. The environment is deadline sensitive and may be exposed to high-pressure situations.
• Travel requirements are minimal. Total travel expected to be less than 5% annually.