Blackfield Associates
Principal Quality Engineer
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Principal Quality Engineer – Risk Management
Are you an experienced Quality Engineer with deep expertise in FMEA and ISO 14971 within a regulated medical device, pharmaceutical, diagnostics, or combination product environment? This is an excellent opportunity to take a lead role in global risk management activities, partnering with cross-functional teams to ensure product quality, patient safety, and regulatory compliance throughout the product lifecycle.
The Opportunity
As 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 Responsibilities
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- Lead 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.
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Essential Requirements
- ✅ Proven experience with FMEA and ISO 14971 is essential
- Minimum 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.
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