ResponsibilitiesThe OpportunityAs Principal Quality Engineer, you will be a key subject matter expert for risk management, driving best practice across design, development, manufacturing, commercialisation and post-market activities. Working within a global organisation, you will provide oversight of enterprise-wide risk management processes and support risk-informed decision making across multiple business functions.Key ResponsibilitiesLead and maintain Product Risk Management Files throughout the product lifecycle.Facilitate risk assessments including hazard identification, risk analysis, risk evaluation and implementation of effective risk controls.Ensure risk management activities are fully aligned with Design Controls, CAPA, Change Control, Non-Conformance and Complaint processes.Drive compliance with global regulations and standards, supporting audit and inspection readiness.Partner with Quality, Regulatory Affairs, R&D, Clinical, Engineering, Manufacturing and Supply Chain teams to embed a proactive risk-based culture.Coach and mentor colleagues on risk management methodologies and best practices.Support continuous improvement initiatives, risk trending, data analysis and process optimisation.RequirementsProven experience with FMEA and ISO 14971 is essentialMinimum 6 years’ experience in Quality, Design & Development or Risk Management within a regulated industry such as medical devices, pharma, diagnostics or combination products.Minimum 4 years’ experience in a Risk Management SME position 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 Failure Modes and Effects Analysis (FMEA).Experience managing Risk Management Files and supporting regulatory submissions, audits and inspections.Excellent stakeholder management and communication skills, with experience working across global teams and multiple time zones.Degree qualified in Engineering, Life Sciences, Quality or a related discipline. Master’s degree advantageous.
Principal Quality Engineer in Southampton 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.
