Head of Risk Management & Quality for Medical Devices

B. Braun Medical Inc. (US); Bethlehem (Northampton County); On-site; USD 135,000 - 168,000; Full time

Job summary

B. Braun Medical Inc.

in Bethlehem, PA seeks a strategic Head of Risk Management to oversee risk programs for pharmaceutical products, medical devices and combination products, ensuring quality, patient safety and regulatory compliance. You will lead a team of risk specialists and applied statisticians, drive harmonized practices with global partners, and implement analytics to reduce risk and improve reliability.

Qualifications

• 6+ years in risk management or related field.
• Experience leading complex projects and driving continuous improvement initiatives.

Responsibilities

• Lead and continuously improve risk management systems 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 industry regulations and standards, including ISO 14971 and ICH Q9.

Skills

Leadership

Risk management

Statistics

Quality systems

Continuous improvement

Usability risk

Cybersecurity risk

Cross-functional collaboration

Communication

Education

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

Master's degree

Professional certification in Risk Management, Quality, Reliability, or related field

Job description

B. Braun Medical Inc.

in Bethlehem, PA seeks a strategic Head of Risk Management to oversee risk programs for pharmaceutical products, medical devices and combination products, ensuring quality, patient safety and regulatory compliance. You will lead a team of risk specialists and applied statisticians, drive harmonized practices with global partners, and implement analytics to reduce risk and improve reliability.