At a Glance
- Tasks: Lead global risk activities and collaborate with design, manufacturing, and regulatory teams.
- Company: Join Blackfield Associates, a leader in quality engineering.
- Benefits: Competitive salary, mentorship opportunities, and a focus on patient safety.
- Other info: Dynamic role with opportunities for professional growth and development.
- Why this job: Make a real impact on patient safety and regulatory compliance.
- Qualifications: Expertise in FMEA, ISO 13485, and ISO 14971 required.
The predicted salary is between 63000 - 77000 £ per year.
Blackfield Associates is seeking a Principal Quality Engineer – Risk Management to lead global risk activities across the product lifecycle, partnering with design, manufacturing and regulatory teams. The role requires deep expertise in FMEA, ISO 13485 and ISO 14971, with proven ability to drive risk assessments, maintain RM files and support regulatory submissions.
You will mentor colleagues, embed a proactive risk-based culture and help ensure patient safety and regulatory readiness.
Global Risk & Quality Lead (FMEA, ISO 13485) employer: Blackfield Associates
At Blackfield Associates, we pride ourselves on being an exceptional employer, particularly for the role of Plant Quality Manager in Folkestone. Our commitment to fostering a collaborative work culture is complemented by robust employee growth opportunities and a focus on continuous improvement, ensuring that our team members thrive both personally and professionally. With a strong emphasis on quality and regulatory compliance, we offer a dynamic environment where your expertise will be valued and your contributions will directly impact our success.
