Senior Global Quality Systems Specialist

The Senior Global Quality Systems Specialist has the responsibility to execute to the global Quality System requirements. This position reports to the leadership of Quality Systems.

• Facilitates change control review meetings and cross-functional alignment on product changes.
• Analyzes change orders to ensure compliance to GDP requirements and existing procedures.
• Lead global issue escalation forums and facilitate cross-functional resolution of high-impact issues.
• Monitor Quality Systems metrics, including but not limited to:
  Audits, IE, CAPA, and NC.
• Assist in quality planning and contribute to QMS review meetings.
• Conduct Quality Systems training sessions and evaluate training effectiveness.
• Execute training strategy and facilitate feedback and improvements.
• Lead and execute internal audits while providing support for external audits conducted across ASP sites.
• Act as a resource for colleagues with less experience.
• Solves complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information.
• Explains difficult or sensitive information; works to build consensus for quality initiatives.
• Collaborate cross functionally to support projects as assigned by direct manager.
• Responsible for communicating business related issues or opportunities to next management level.
• Supports continuous improvement initiatives.
• Perform other duties as assigned.

• In-depth knowledge of QMS and regulatory requirements.
• Excellent written and verbal communication skills (English).
• Demonstrated ability to train, mentor, and coordinate the work of others in daily operations.
• Seeks to deeply understand customer needs and prioritize work accordingly.
• Willing to take on the unknown and overcome adversity to support the goals of the business.
• Seeks varied perspectives and experiments with new ways of solving problems.
• Collaborates in support on team’s success.
• Demonstrates urgency and ownership to consistently deliver on objectives using FBS.

• Bachelor’s degree in engineering, science, or related field.
• Minimum 5 years of experience in a quality or regulatory role in medical devices or related regulated industry.
• Equivalent combination of education and experience will be considered.

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.

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…