Sr. Quality Engineering Manager

Neurocrine Biosciences • San Diego, CA

1d

About The Position

Provides senior-level Quality Engineering leadership across the medical device product lifecycle, ensuring compliance with regulatory standards and effective risk management in development and manufacturing activities. Serves as a subject matter expert and partner to cross-functional teams, leading complex investigations, supplier quality oversight, and quality system improvements. Drives data-informed quality strategy and operational excellence through KPI monitoring, risk mitigation, and continuous improvement initiatives supporting device constituents.

Requirements

• BS/BA degree AND 8+ years of relevant experience OR Master’s AND 6+ years of related experience OR JD or PharmD or PhD AND 4+ years of related experience
• Ability to independently problem-solve and execute and monitor corrective actions
• Ability to interpret data and analyze trends to provide insight into potential issues
• Strong communication, facilitation, planning, problem-solving, and organizational skills appropriate to experience level
• Excellent attention to detail, well organized and able to work independently and as a team
• Good judgment and decision-making skills; knows how to make trade-off decisions while balancing compliance and business impact preferred
• Practical experience in FDA and ISO regulated environments
• Knowledgeable in technical guidance documents from FDA, EMA, PDA, ISPE, ICH, ISO, PIC/S and other organizations for drugs, biologics, and medical devices, and able to apply the content of these to new and existing manufacturing processes
• Experience with medical device evaluation and production including planning processes, process controls, capability analysis, material control, acceptance sampling and measurement systems
• An understanding of CGMPs and their applicability to everyday work

Responsibilities

• Provide Quality Engineering leadership across the product lifecycle, ensuring effective quality oversight for medical devices and combination products
• Lead and facilitate complex risk management activities (e.g., Hazard Analysis, FMEA, PFMEA), ensuring alignment with applicable regulatory standards and integration of risk-based decision making across development and manufacturing processes
• Oversee and ensure the integrity and completeness of the Design History File (DHF) for medical devices and combination products, providing guidance to cross-functional teams on documentation strategy and regulatory expectations
• Lead complex investigations and root cause analyses related to device constituents, driving cross-functional collaboration to identify risks, implement corrective actions, and ensure sustainable outcomes
• Serve as a subject matter expert on applicable regulations and standards (including ISO 13485, ISO 14971, ISO 10993), advising cross-functional teams and guiding compliant device development and lifecycle management activities
• Drive the development, monitoring, and continuous improvement of Key Performance Indicators (KPIs) utilizing multiple data sources to identify trends, inform quality strategy, and enable data-driven decision making
• Assess, prioritize, and mitigate quality and compliance risks associated with manufacturing processes, recommending and implementing improvements to strengthen quality systems and operational performance
• Provide strategic updates and risk-based insights to senior leadership on program status, quality metrics, and emerging issues, proactively escalating critical concerns and recommending mitigation strategies
• Participate in supplier quality oversight activities, including evaluation, qualification, and ongoing performance monitoring of device component suppliers
• Lead supplier audits and ensure effective follow-up of audit observations to maintain supplier compliance and continuous improvement
• Oversee non-conformance management and failure investigations for device constituents, ensuring effective CAPA/SCAR implementation and sustainable resolution of systemic quality issues
• Provide expert Quality Engineering guidance internal stakeholders supporting medical device and combination product development, ensuring alignment with regulatory expectations and internal quality standards
• Drive continuous improvement initiatives within the quality system, contributing to the advancement of processes, tools, and best practices that support organizational quality objectives
• Perform other responsibilities as assigned in support of departmental and organizational priorities

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level