5 years quality design controls risk management experience
Iso 14971 and iso 13485 regulatory knowledge
Fda 21 cfr 820 compliance expertise
The role is responsible for implementing and ensuring compliance with design control and risk management requirements throughout the life cycle of BD's dispensing medical devices
Job Summary
The role is responsible for implementing and ensuring compliance with design control and risk management requirements throughout the life cycle of BD's dispensing medical devices.
Candidates must lead cross-functional teams to identify hazards, estimate risks, and ensure all necessary risk management activities are carried out in accordance with the quality system.
BD offers a culture that prioritizes on-site collaboration to foster creativity, innovation, and effective problem-solving within the fast-paced healthcare industry.
Matching Summary
The role is responsible for implementing and ensuring compliance with design control and risk management requirements throughout the life cycle of BD's dispensing medical devices.
Salary
Base: $126,600.00 - $208,900.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive Total Rewards program including performance-based culture
Skills & Requirements
Must-have
5 years Quality Design Controls Risk Management experience
ISO 14971 and ISO 13485 regulatory knowledge
FDA 21 CFR 820 compliance expertise
FMEA process implementation and remediation
Post-market complaint trending and data analytics
Nice-to-have
Strong oral and written communication skills
Ability to adapt to rapidly changing environment
Mentoring and coaching cross-functional teams
Strategic planning and continuous improvement mindset