Global Quality Systems Specialist
Top Benefits
About the role
Location: Open to remote in US, Canada, Mexico, Brazil, Colombia, Argentina
The Global Quality Systems Specialist at Advanced Sterilization Products has the responsibility to execute to the global Quality System requirements. This position reports to the leadership of Quality Systems.
Responsibilities
- Manages document revisions, ensures compliance with formatting and approval workflows
- Coordinate change control documentation and facilitate cross functional review.
- Analyzes change orders to ensure compliance to GDP requirements and existing procedures.
- Track and monitor quality systems metrics, including but not limited to: IE, CAPA and NC
- Support timely documentation and closure
- Assist in quality planning activities and QMS review preparation.
- Manage training assignments and monitor training metrics
- Participate in internal audits and support audit readiness activities.
- Support internal audit logistics such as scheduling
- Provide informal guidance to new team members.
- Solves problems in straightforward situations; analyzes possible solutions using technical experience and judgment and precedents
- Explains complex information to others in straightforward situations
- Collaborate with cross-functional teams to resolve issues.
- 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.
Qualifications
- Working knowledge of quality management systems and experience with ISO 13485.
- 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
Experience And Education
- Bachelor’s degree in engineering, science, or related field.
- Minimum 3 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 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 applyassistance@fortive.com.
Bonus or Equity This position is also eligible for bonus as part of the total compensation package.
Pay Range The salary range for this position (in local currency) is 70,600.00 - 117,900.00
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 applyassistance@fortive.com.
This position is also eligible for bonus as part of the total compensation package.
The salary range for this position (in local currency) is 70,600.00 - 117,900.00
About Advanced Sterilization Products
In healthcare, nothing is more important than protecting patients. So it’s vital to ensure the safety of the care environment – especially the medical devices and equipment that come into contact with vulnerable patients.
ASP is a global leader in infection prevention solutions for healthcare. With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities.
Add your voice and talents to our extraordinary Fortive/ASP team, and help us make healthcare safer for everyone.
ASP is based in Irvine, California, USA with core sites in Everett, Washington, and Schaffhausen, Switzerland plus many more offices around the world.
Please visit ASP at www.ASP.com
To view all open opportunities within ASP click the link below -- https://careers.fortive.com/asp/
Global Quality Systems Specialist
Top Benefits
About the role
Location: Open to remote in US, Canada, Mexico, Brazil, Colombia, Argentina
The Global Quality Systems Specialist at Advanced Sterilization Products has the responsibility to execute to the global Quality System requirements. This position reports to the leadership of Quality Systems.
Responsibilities
- Manages document revisions, ensures compliance with formatting and approval workflows
- Coordinate change control documentation and facilitate cross functional review.
- Analyzes change orders to ensure compliance to GDP requirements and existing procedures.
- Track and monitor quality systems metrics, including but not limited to: IE, CAPA and NC
- Support timely documentation and closure
- Assist in quality planning activities and QMS review preparation.
- Manage training assignments and monitor training metrics
- Participate in internal audits and support audit readiness activities.
- Support internal audit logistics such as scheduling
- Provide informal guidance to new team members.
- Solves problems in straightforward situations; analyzes possible solutions using technical experience and judgment and precedents
- Explains complex information to others in straightforward situations
- Collaborate with cross-functional teams to resolve issues.
- 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.
Qualifications
- Working knowledge of quality management systems and experience with ISO 13485.
- 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
Experience And Education
- Bachelor’s degree in engineering, science, or related field.
- Minimum 3 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 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 applyassistance@fortive.com.
Bonus or Equity This position is also eligible for bonus as part of the total compensation package.
Pay Range The salary range for this position (in local currency) is 70,600.00 - 117,900.00
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 applyassistance@fortive.com.
This position is also eligible for bonus as part of the total compensation package.
The salary range for this position (in local currency) is 70,600.00 - 117,900.00
About Advanced Sterilization Products
In healthcare, nothing is more important than protecting patients. So it’s vital to ensure the safety of the care environment – especially the medical devices and equipment that come into contact with vulnerable patients.
ASP is a global leader in infection prevention solutions for healthcare. With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities.
Add your voice and talents to our extraordinary Fortive/ASP team, and help us make healthcare safer for everyone.
ASP is based in Irvine, California, USA with core sites in Everett, Washington, and Schaffhausen, Switzerland plus many more offices around the world.
Please visit ASP at www.ASP.com
To view all open opportunities within ASP click the link below -- https://careers.fortive.com/asp/