Manager, Product Quality

Fortive • Irvine, CA

9h

About The Position

Leads a global team responsible for executing scalable product quality activities across design quality and customer quality. The role ensures high-quality, compliant, and efficient delivery of verification and validation activities, distributed product quality management, complaint intake, and quality data insights.

Requirements

• Bachelor’s degree (or equivalent experience) in Engineering, Quality, Computer Science, Life Sciences, or related discipline.
• Minimum 6 years of experience in Product Quality, Design Quality, Customer Quality, or related field within medical device industry.
• Minimum 2 years of experience leading or supervising professional employees or teams.
• Demonstrated ability to lead and develop professional teams while driving accountability for results.
• Strong working knowledge of design controls, verification and validation, complaint handling, and post-market quality processes.
• Ability to apply risk-based thinking and problem-solving to operational and technical quality challenges.
• Experience driving process standardization, continuous improvement, scalable operating models, QMS workshops, Kaizen events, standard work deployment, and sustainment of process improvements.
• Data-driven mindset with ability to leverage analytics to identify trends, risks, and performance gaps.
• Strong communication skills to convey expectations, escalate issues, and guide stakeholders.
• Knowledge of 21 CFR Part 820, ISO 13485, and EU MDR.
• Experience in quality systems within medical device, pharmaceutical, or other regulated industry.
• Experience supporting regulatory compliance inspections and audits.

Nice To Haves

• Process excellence tools/methodologies (Six Sigma, FBS, etc.).
• Good working knowledge of several FBS tools.

Responsibilities

• Lead, coach, and develop a team of product quality professionals to deliver high-quality execution across design and customer quality workstreams.
• Manage software verification and validation (V&V) execution, ensuring compliant, complete, and scalable delivery aligned to design controls and product lifecycle requirements.
• Manage complaint intake, support APAC complaint investigations, ensuring quality, timeliness, and escalation of emerging product risks.
• Own the end-to-end product quality lifecycle for distributed products.
• Develop and maintain product quality dashboards and reporting to enable data-driven decision making and visibility of product performance and risk signals.
• Implement scalable operating mechanisms, including standard work, automation, risk-based work tiering, and structured QMS workshop/Kaizen activities to improve efficiency, strengthen compliance, and reduce the cost of poor quality.
• Ensure compliance with quality system requirements and regulatory expectations, maintaining audit readiness and robust documentation practices.
• Collaborate globally and cross-functionally with RAQA, R&D, IT, Operations, Manufacturing, Supplier Quality, and regional teams to ensure clear interfaces, effective handoffs, alignment on quality priorities, and sustained execution of improvement initiatives.

What This Job Offers

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