Business Process Owner, Risk Management

Risk Management Business Process Owner (BPO), Dispensing

The Risk Management Business Process Owner (BPO), Dispensing is accountable for influencing risk management process activities for product development and product maintenance through the application of quality management and engineering skills for medical devices. This person will support Engineers from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and business unit policies, while meeting all risk management and other regulatory requirements. This person may also assist with compliance remediation, design control, change control, or wider product development process management projects.

Responsibilities :

• Applies medical device development expertise to provide leadership in the creation and maintenance of product risk management processes based in 14971 regulation.
• The Business Process Owner provides strategic and tactical direction and oversight to ensure consistent leadership for Product Risk Management.
• This individual monitors internal and external regulatory observations and trends and implements changes across the business units.
• This position will also participate in other QMS tactical and strategic activities as needed, including but not limited to Design Control and Change Control process activities.

Education and Experience :