Sr Quality Engineer

Position: Sr Quality Engineer I
* Develop key relationships and interface extensively with internal stakeholders to address and resolve quality and compliance issues related to drug-device combination products.
* Identify gaps in existing processes and lead cross-functional teams to develop and implement solutions.
* Write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Work Instructions).
* Work with management and department personnel to achieve goals and strategic initiatives.
* Identify, plan, and execute changes to quality processes to ensure conformance and continuous improvement.
* Ensure changes to commercial products comply with FDA QSR/QMSR, ISO 13485, and other applicable standards.
* Maintain compliance with global Risk Management processes in accordance with ISO 14971 and other applicable standards.
* Collaborate with SMEs from R&D, Clinical, and Operations to ensure comprehensive application of risk processes.
* Participate in annual product reviews and periodic updates of DHF and RMF.
* Maintain expertise in current and emerging requirements and quality trends for Pharmaceuticals, Medical Devices, and Combination Products worldwide.
* Support due diligence and internal/external audits or inspections as needed.
* Assist with complaint investigations and communicate findings to design, development teams, and CMOs.
* Stay abreast of evolving regulatory requirements to ensure compliance of commercial products.
* May support design and development activities as required.
* Bachelor’s degree in science or engineering-related field with at least 6 years of experience in the medical device industry, OR Master’s degree with at least 4 years of relevant experience.
* In-depth knowledge of Quality principles, concepts, industry practices, and standards.
* Quality experience in both clinical and commercial products.
* Strong understanding of U.S. and international quality systems regulations/standards.
* Ability to work independently and in a global team environment.
* Excellent interpersonal and communication skills.
* Previous experience with combination devices (e.g., autoinjectors, pre-filled syringes).
* Well-versed in risk management methodologies and tools (e.g., Hazard Analysis, FMEA).
* Knowledge of ISO 14971 Risk Management processes.
* ASQ certifications (Certified Quality Auditor, Certified Quality Engineer, Certified Quality Manager) or equivalent.
* Familiarity with emerging regulatory requirements and ability to drive continuous improvement initiatives.
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