Staff QA Engineer - Risk Management
Possesses a thorough understanding of the requirements and has direct experience with the implementation of ISO standards for medical devices with emphasis on medical device risk management (EN ISO 14971:2012).
The staff QA risk management engineer provides oversight on the implementation of the Beckman Coulter product safety risk management process for new product development projects, design changes, and facilitates risk management activities in compliance with Beckman Coulter procedures. The incumbent is responsible for teaching, coaching, and mentoring team members on risk management and approving all risk management deliverables. The risk specialist acts as a subject matter expert on risk management and provides support across the broader organization.
The risk specialist acts as the expert in risk evaluation for post market issues for product safety and provides guidance on the completion of the risk documents. The risk specialist approves all post launch risk assessments and facilitates the decision-making process among the stake holders.
The staff QA risk management engineer exercises independent judgment in evaluating complex processes, procedures and systems against written regulatory requirements and company procedures. Possesses excellent collaboration skills and can resolve conflicts independently. Possesses a high degree of analysis and judgment. Effective communication, teamwork, and negotiation skills are required to work with personnel at all levels of the organization
The position will cover QA risk management oversight for the Miami, Florida product lines: hematology, urinalysis, and flow Cytometry.
Bachelor’s Degree in Scientific or Engineering discipline with 10 years of medical device experience, Master’s Degree with 8 years of medical device experience, or Ph.D. with 6 years of medical device experience. Experience with risk management for medical devices is desirable.
o Ability to drive results, foster teamwork, handle pressure, and provide feedback
o Experience participating on cross functional teams
Personal Skills and Attributes:
o Ability to perform detail-oriented work with a high degree of accuracy.
o Proven ability to work cross-functionally in a team-based environment.
o Proficient in MS Office Suite of products.
o Willingness to be flexible and adaptable to changing priorities.
o Excellent oral and written communication skills.
o Effective analytical and problem-solving skills.