Manager, Product Quality

Advanced Sterilization Products; India; On-site; INR 2,400,000 - 4,200,000; Full time

Job summary

Advanced Sterilization Products in India is seeking a Manager, Product Quality to lead a global team driving scalable quality activities across design and customer quality. You will own end-to-end quality lifecycle, ensure compliance with design controls, and develop dashboards for data-driven decisions.

The role requires 6+ years in medical device quality and 2+ years of people leadership, with strong knowledge of 21 CFR Part 820, ISO 13485, and EU MDR, and a willingness to travel.

Qualifications

• Bachelor’s degree 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.

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.

Skills

Leadership

Quality management

Regulatory knowledge

Data-driven decision making

Education

Bachelor's degree in Engineering/Quality/CS/Life Sciences

Tools

Six Sigma

FBS

Job description

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

• 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, elevate 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.

Fortive Corporation Overview

Fortive's essential technology makes the world safer and more productive. We accelerate transformation in high-impact fields like workplace safety, build environments, and healthcare.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in healthcare sterilization, industrial safety, predictive maintenance, and other mission-critical solutions. 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 advanced technologies that help providers focus on exceptional patient care.

We are a diverse team 10,000 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.

About Advanced Sterilization Products

ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.

ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality.

ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning.

We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at [e-mail].

Bonus or Equity

This position is also eligible for bonus as part of the total compensation package.