Overview
As Principal Quality Engineer, you will lead enterprise-wide risk management across the product lifecycle to support risk-informed decision making. You will embed a proactive risk-based culture within global cross-functional teams, ensuring compliance with regulatory standards. You’ll drive risk governance, guide teams through FMEA and ISO 14971 applications, and partner across Quality, Regulatory Affairs, R&D, and Manufacturing to enable safer, compliant products. This role offers influence on audits, inspections, and continuous improvement initiatives with meaningful impact on product quality and patient safety.
Responsibilities
- Lead and maintain Product Risk Management Files across the product lifecycle
- Facilitate hazard identification, risk analysis, evaluation and control implementation
- Align risk activities with Design Controls, CAPA, Change Control, Non-Conformance and Complaint processes
- Drive regulatory compliance, audit readiness and inspections support
- Collaborate with Quality, Regulatory Affairs, R&D, Clinical, Engineering, Manufacturing and Supply Chain to embed risk-based culture
- Coach and mentor colleagues on risk management methodologies
- Support data analysis, risk trending and process optimization for continuous improvement
Key requirements
- Proven experience with FMEA and ISO 14971 is essential
- ≥6 years in Quality, Design & Development or Risk Management within a regulated industry (medical devices, pharma, diagnostics or combination products)
- ≥4 years in a Risk Management SME role applying ISO 14971
- Strong knowledge of ISO 14971, ISO 13485, ISO 10993, IEC 62366, EU MDR, FDA QSR/QMSR and Design Controls
- Demonstrated expertise in risk management tools and methodologies, including FMEA
- Experience managing Risk Management Files and supporting regulatory submissions, audits and inspections
- Excellent stakeholder management and communication across global teams
- Engineering, Life Sciences, Quality or related degree (Master’s advantageous)
- Stakeholder management
- Cross-functional collaboration
- Mentoring/coaching
- FMEA
- ISO 14971
- ISO 13485
Principal Quality Engineer in Hampshire employer: Blackfield Associates
Join a leading pharmaceutical company in Slough as a Scientist in Antibody Formulation Development, where you will be part of a dynamic team that plays a crucial role in advancing innovative therapies. The company fosters a collaborative work culture, offering extensive opportunities for professional growth and development, alongside competitive benefits that support work-life balance. With a focus on cutting-edge research and a commitment to employee well-being, this is an excellent opportunity for those seeking meaningful and rewarding employment in the biotechnology field.
