Job Title
Manager, Product Quality
Job summary
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.
Key Responsibilities
Under minimal supervision, general direction, and in accordance with applicable government laws, regulations, and ASP policies, procedures, and guidelines, this position shall:
- 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.
Education and Experience 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.
Role and Competencies Requirements
- 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.
- Process excellence tools/methodologies (Six Sigma, FBS, etc.).
- Good working knowledge of several FBS tools.
- Travel: Domestic and International.
Skills Required
- Bachelor's degree (or equivalent) in Engineering, Quality, Computer Science, Life Sciences, or related discipline
- Minimum 6 years experience in Product Quality, Design Quality, Customer Quality, or related field within the medical device industry
- Minimum 2 years experience leading or supervising professional employees or teams
- Strong working knowledge of design controls, verification and validation (V&V), complaint handling, and post-market quality processes
- 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
- Experience driving process standardization, continuous improvement, QMS workshops/Kaizen, and standard work deployment
- Familiarity with process excellence tools/methodologies (Six Sigma, FBS) and related FBS tools
- Data-driven mindset with ability to leverage analytics to identify trends, risks, and performance gaps
- Demonstrated ability to lead and develop professional teams while driving accountability for results
- Willingness to travel domestically and internationally
Fortive Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Fortive and has not been reviewed or approved by Fortive.
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Parental & Family Support — Parental leave is fully paid for 12 weeks for all parents, with fertility coverage via Progyny and generous adoption/surrogacy support. Backup child and adult care plus inclusive eligibility extend support across diverse family structures.
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Healthcare Strength — Multiple PPO and HSA medical options include telemedicine and second-opinion services, alongside robust mental-health access through Spring Health with no‑cost therapy sessions. The breadth of medical and behavioral health resources is highlighted as a strength.
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Retirement Support — The 401(k) provides a competitive employer match each pay period, with an additional company retirement contribution after one year of service. Financial wellness tools and an employee stock purchase plan further bolster long‑term savings.
Fortive Insights
What We Do
Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions. We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions. We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact. At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference. At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone. At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating. Fortive: For you, for us, for growth.
