Risk Management Lead for Pharma & Medical Devices

RXinsider LTD.; Bethlehem (Northampton County); On-site; USD 135,000 - 168,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. is seeking a strategic Head of Risk Management to lead risk programs for pharmaceutical products, medical devices and combination products.

This leadership role oversees risk management systems, statistical methods, and continuous improvement to support product quality and patient safety. You will manage a team of risk management specialists and applied statisticians while collaborating with global teams to harmonize practices and implement electronic systems that reduce

Qualifications

• Bachelor's degree in Engineering, Quality, Statistics, Life Sciences, or a related field required.
• 6+ years of experience in risk management, quality, reliability, engineering, or related discipline.
• Experience leading complex projects and driving continuous improvement initiatives.

Responsibilities

• Lead and continuously improve risk management systems and processes across the product lifecycle.
• Identify and mitigate product and process risks while promoting a culture of quality and safety.
• Manage and develop a team of Risk Management Specialists and Applied Statisticians.
• Drive the use of risk management and statistical tools to improve product reliability and manufacturing performance.
• Partner with global teams to standardize risk management practices and implement harmonized electronic systems.
• Ensure compliance with ISO 14971 and ICH Q9.

Skills

Leadership

Risk management

Statistics

Quality systems

Usability risk management

Cybersecurity risk management

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Quality, Statistics, Life Sciences, or related field

Master's degree

Professional certification in Risk Management

Job description

B. Braun Medical Inc. is seeking a strategic Head of Risk Management to lead risk programs for pharmaceutical products, medical devices and combination products.

This leadership role oversees risk management systems, statistical methods, and continuous improvement to support product quality and patient safety. You will manage a team of risk management specialists and applied statisticians while collaborating with global teams to harmonize practices and implement electronic systems that reduce