The role of Manager,Market Quality will promote create / improve standards of quality within thedesignated region(s) by influencing and managing all quality relatedactivities.
This role will work closelywith the Sr. Manager, Market Quality and / or Market Quality Director to developand implement Quality strategy and provide strategic leadership to thedesignated region(s).
The individual willinteract with and provide oversight to local operating companies to ensureadherence to the ASP quality management system and local / in countryregulations.
Duties andResponsibilities Under limitedsupervision and in accordance with all applicable government laws, regulationsand ASP policies, procedures and guidelines, this position :
Implements and oversees the ASP Quality ManagementSystem and its integrated programs within the respective region, such asquality systems training, internal audits, nonconformances, corrective andpreventive action, records management, field actions, supplier qualitymanagement, procurement, servicing, distribution, and post marketsurveillance.
Assures compliance with applicable regulations such as,but not limited to, FDA 21 CFR 820, ISO 13485, EU MD Directive / Regulations,Japan JPAL, Canada CMDCAS, Brazilian ANVISA, and Austrailian TGA.
Maintains, sustains and continuously improves theQuality Management System and monitors the performance and health of theQuality Management System through metrics and analytics.
May serve as in-country Quality representative alignedwith local regulations or laws (e.g. Mexico Sanitary responsible).
Participates and hosts internal and external audits. Mayserve as liason between local health authority and the business.
Maintains a comprehensive audit readiness program toensure internal and external quality compliance.
Maintains knowledge of regulatory changes throughregulatory standard management process and close cooperation with regulatoryaffairs.
Establish local and regional relationships withregulatory affairs,commercial, and logistics team.
Maintains quality oversight of local distribution andwarehouse management process (assessment, qualification, monitoring).
Maintains quality oversight of any local requiredestablishment licences, or QMS certifications.
Maintains local supplier / vendor selection,qualification, and audits.
Maintains process for kitting / repack / relabelingactivities (if any)
Maintains quality records and adherence to recordsretention policies and procedures.
Maintains quality oversight of field serviceprocesses / procedures.
Maintains quality training program with respect toquality system elements.
Establish corrective and preventive actions to mitigatepotential or actual noncompliance risks.
Assesses product quality issues and escalates to uppermanagement through established processes.
Ensures timely post-market surveillance & vigilance(Field Actions and Product Complaints) management
Ensures timely and consistent escalation of events.
Responsible for communicating business related issues oropportunities to next management level
Performs other duties assigned as needed.
Participates and hosts internal and external audits
Promotes a culture of quality and compliance throughoutthe organization.
Supports departmental and franchise objectivies, whileadhering to the ASP core values, as well as local safety and environmentalpolicy and procedures.
Bachelor's degree in Engineering, Life Sciences, or equivalent field required. + Years of Related Experience : Minimum of 6 years of experience in medical device or pharma regulated environment in the areas of Quality, R&D, Manufacturing, or related field.
At least 3 years experience in the Medical Device industry + Demonstrated knowledge of regulatory standards and regulations, FDA 21 CFR 820, EU MD Directive / Regulations, Japan PAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA, ISO 13485, ISO 9001, ISO 14971.
Ability to effectively negotiate and influence above, below and across the organization + Ability to work and communicate in a cross-cultural environment.
Excellent communication skills both written and verbal + Business fluent in Spanish, Portugiese and English, Italian is a big advantage + Highly developed influence, interpersonal, communication and conflict resolution skills + Ability to interact with all levels and disciplines within the organization + Must be able to work on multiple priorities and tasks simulataneously, while acting in a decisive manner and demonstrating a bias for action + High sense of urgency, adaptable to meet rapidly changing priorities + Proven analytical / quantitative skills + Project management skills, with the ability 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.