Manager, Market Quality

South Africa, South Africa

Job Description

The role of Manager, Market Quality will promote create/improve standards of quality within the designated region(s) by influencing and managing all quality related activities. This role will work closely with the Sr. Manager, Market Quality and/or Market Quality Director to develop and implement Quality strategy and provide strategic leadership to the designated region(s).
The individual will interact with and provide oversight to local operating companies to ensure adherence to the ASP quality management system and local/in country regulations.
Duties and Responsibilities
Under limited supervision and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:

  • Implements and oversees the 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 Australian 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.
  • May serve as in-country Quality representative aligned with local regulations or laws (e.g. Mexico Sanitary responsible).
  • Participates and hosts internal and external audits. May serve as liaison between local health authority and the business.
  • Maintains a comprehensive audit readiness program to ensure internal and external quality compliance.
  • Maintains knowledge of regulatory changes through regulatory standard management process and close cooperation with regulatory affairs.
  • Establish local and regional relationships with regulatory affairs,commercial, and logistics team.
  • 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.
  • Participates and hosts internal and external audits
  • Promotes a culture of quality and compliance throughout the organization.
  • Supports departmental and franchise objectives, while adhering to the ASP core values, as well as local safety and environmental policy 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
Knowledge, 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 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
  • 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
  • Project management skills, with the ability to drive change and influence decision making through multiple levels.
Responsibility For Others and Internal Interactions
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.
External Interactions
This role may be required to interface with health authorities and notified bodies, and may interact with customers as part of post market surveillance and vigilance follow ups or customer site visits with commercial or field service organizations.
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.

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Job Detail

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    Full Time
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  • Job Location
    South Africa, South Africa
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