Senior) Market QualitySpecialist ensures development and implementation of quality systems incompliance with
established standards and support localregion. The individual will interact with and provide oversight to localoperating companies to ensure adherence to the ASP quality management systemand local / in country regulations.
Supports the Market Quality Manager andthe local commercial team on all applicable government laws, regulations and
ASP policies, procedures and guidelines,this position :
Implements and supports ASP QualityManagement System and its integrated programs within the respective
region, such as quality systems training,internal audits, nonconformances, corrective and preventive action, records
management, field actions, supplierquality management, procurement, servicing, distribution, and post market
Assures compliance with applicableregulations such as, but not limited to, FDA 21 CFR 820, ISO 13485, EU MD
Directive / Regulations, Japan JPAL, CanadaCMDCAS, Brazilian ANVISA, and Australian TGA.
Maintains, sustains and continuouslyimproves the Quality Management System and monitors the performance and
health of the Quality Management Systemthrough metrics and analytics.
May serve as in-country Qualityrepresentative aligned with local regulations or laws (e.g. Mexico Sanitary
Participates and hosts internal andexternal audits. May serve as liaison between local health authority and the
Supports quality team for a comprehensiveaudit readiness program to ensure internal and external quality
Maintains knowledge of regulatorychanges through regulatory standard management process and close cooperation
with regulatory affairs.
Establish local and regional relationshipswith regulatory affairs, commercial, and logistics team.
Maintains quality oversight of localdistribution and warehouse management process (assessment, qualification,
Maintains quality oversight of any localrequired establishment licenses, or QMS certifications.
Maintains local supplier / vendorselection, qualification, and audits.
Maintains process forkitting / repack / relabeling activities (if any)
Maintains quality records and adherenceto records retention policies and procedures.
Maintains quality oversight of fieldservice processes / procedures.
Maintains quality training program withrespect to quality system elements.
Establish corrective and preventiveactions to mitigate potential or actual noncompliance risks.
Assesses product quality issues andescalates to upper management through established processes.
Ensures timely post-market surveillance& vigilance (Field Actions and Product Complaints) management
Ensures timely and consistent escalationof events.
Responsible for communicating businessrelated issues or opportunities to next management level
Performs other duties assigned asneeded.
BS / BS degree (science or engineeringpreferred) at minimum
5 years of related experience
Training of medical device regulationsto include ISO 13485 and 21 CFR 820 at minimum
Six Sigma Process Excellence and / or LeanExcellence Green Belt trained (preferred)
ISO 13485 lead auditor qualifications(preferred)
Minimum of 5 years of experience inmedical device or pharma regulated environment in the areas of Quality,R&D,
Manufacturing, or related field.
At least 3 years experience in theMedical Device
Demonstrated knowledge of regulatorystandards and regulations, FDA 21 CFR 820, EU MD Directive / Regulations,
JapanPAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA, ISO 13485, ISO 9001,ISO 14971.
Ability to effectively negotiate andinfluence above, below and across the organization Ability to work andcommunicate
in a cross-cultural environment.
Excellent communication skills bothwritten and verbal
Business fluency in Spanish and Englishis a must, Portuguese, French or Italian is a big asset
Highly developed influence, interpersonal,communication and conflict resolution skills
Ability to interact with all levels anddisciplines within the organization
Must be able to work on multiplepriorities and tasks simultaneously, while acting in a decisive manner and
demonstrating a bias for action
High sense of urgency, adaptable to meetrapidly changing priorities
Proven analytical / quantitative skills
Project management skills, with theability to drive change and influence decision making through multiple levels
Fortive is a global family of more than 20 industry-leading industrial growth and technology companies, united by a shared purpose : to make the world stronger, safer, and more effective by providing essential technology for the people who accelerate progress.
Here, you get the excitement of a startup with the stability and predictability of an organization strongly grounded in its roots and with a proven track record of growth.
There’s no limit to what you can learn, or the impact you can make : for you, for us, for growth. Come join our team at Advanced Sterilization Products (ASP) and be part of a global leader in infection prevention solutions for the healthcare industry.
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 talent to our extraordinary team and help us in our mission to make healthcare safer for everyone. ASP is based in Irvine, California with core sites in Everett, Washington and Schaffhausen, Switzerland plus many more offices around the world.