Senior Quality Engineer II — Regulatory & Risk Lead

Werfen; Bedford; On-site; GBP 90,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Employer pension plan with employer 2%

Paid vacation and sick leave

Job summary

Werfen in the United Kingdom is seeking an experienced professional to oversee regulatory compliance across the product lifecycle, influencing design, development, production and service processes.

The role requires leadership in applying quality systems, risk management and CAPA, with expertise in IL products and manufacturing practices to ensure sustained regulatory compliance and product excellence.

Qualifications

• Knowledge of domestic and international quality/regulatory standards.
• Lean Six Sigma and statistical techniques to measure changes.
• Understanding of IL products, technology and manufacturing processes.
• Experience applying regulatory requirements to data review, risk management and design changes.

Responsibilities

• Ensure compliance with procedures, standards and regulations across the product lifecycle.
• Lead cross-functional teams on quality improvements and CAPA actions.
• Review and approve change orders affecting product performance, processes, labeling and marketing communications.
• Provide guidance on software compliance including cyber security and privacy requirements.
• Support audits, risk assessments and product realization activities.

Skills

Quality/regulatory standards

Lean Six Sigma

Risk management

IL products knowledge

Education

Bachelor's degree in engineering or science

Job description

Werfen in the United Kingdom is seeking an experienced professional to oversee regulatory compliance across the product lifecycle, influencing design, development, production and service processes.

The role requires leadership in applying quality systems, risk management and CAPA, with expertise in IL products and manufacturing practices to ensure sustained regulatory compliance and product excellence.