Supports the Market Quality Manager and the local commercial team on all applicable government laws, regulations and ASP policies, procedures and guidelines, this position :
Implements and supports ASP Quality Management 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, supplier quality management, procurement, servicing, distribution, and post market surveillance.
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 the Quality Management System and monitors the performance and health of the Quality Management System through metrics and analytics.
Maintains quality oversight of local distribution and warehouse management process (assessment, qualification, monitoring).
Maintains quality oversight of any local required establishment licences, or QMS certifications.
Maintains local supplier / vendor selection, qualification, and audits.
Maintains process for kitting / repack / relabeling activities (if any)
Maintains quality records and adherence to records retention policies and procedures.
Maintains quality oversight of field service processes / procedures.
Maintains quality training program with respect to quality system elements.
Establish corrective and preventive actions to mitigate potential or actual noncompliance risks.
Assesses product quality issues and escalates to upper management 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 or opportunities to next management level
Performs other duties assigned as needed. Qualifications : Education : Required Minimum Education 0 or Equivalent-BS / BS degree (science or engineering preferred) at minimum-5 years of related experience-Training of medical device regulations to include ISO 13485 and 21 CFR 820 at minimum-Six Sigma Process Excellence and / or Lean Excellece Green Belt trained (prefered)-ISO 13485 lead auditor qualifications (preferred)Years of Related Experience : Minimum of 5 years of experience in medical device or pharma regulated environment in the areas of Quality, R&D, Manufacturing, or related field.
At least 5 years experience in the Medical Device industryKnowledge, Skills, Abilities, Certifications / Licenses, and Affiliations : (Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)
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 work and communicate in a cross-cultural environment.
Excellent communication skills both written and verbal
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 mulitplie 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
Responsibility For Others and Internal InteractionsThis role will have direct reports within the responsible regions. This role will work closely with the commercial sales, marketing, technical service, and logistics organization.
In addition, this role will interact with the global quality organization to drive quality systems initiatives in the respective region.
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.