QA Manager Americas

The QA Manager, Americas ensures that all activities performed in the USA and Latin America (LATAM) under the responsibility of HSO comply with the applicable regulations. This person is primarily responsible for compliance with applicable national regulations for the United States, Brazil, Argentina, Uruguay, Peru, Mexico, Colombia, and Ecuador, and other countries HOYA conducts business within the US and LATAM regions.

This role is also responsible for complaint handling and post market activities in these countries, and acts as auditor for Internal Hoya sites, distributors and/or suppliers.

Key duties and Responsibilities

• Establish, implement, and maintain a Quality Management System (QMS) to meet the requirements of ISO 13485 standards as well as local regulations as applicable to USA and LATAM
• Oversee and ensure that quality related processes to support Distribution, Supply Chain and Vigilance activities performed by HOYA in the region comply with local regulations and the applicable parts of HOYA’s Global Quality Management System
• Supervise, monitor, and instruct distributors in the region regarding compliance to product related regulatory requirements, post-market surveillance processes and Good Distribution Practice
• Conduct training and necessary awareness regarding customer complaint management and reportability of adverse events
• Oversee and ensure that distributors working for HOYA in the region meet local regulations and comply with the requirements set out in the relevant Distributor Quality Agreement
• Responsible for adequate and effective management of the relationship with distributors, regulators, HOYA’s local, regional, and global teams, including Quality, Operations, Sales, Marketing, R&D, and GHQ
• Ensure that reportable adverse events and the post-market surveillance activities comply with local regulatory requirements, including, but not limited to customer complaint handling, AE monitoring, vigilance reporting, and FSCA
• Train Hoya employees/distributors in the region on applicable regulations and quality requirements to increase awareness on regulatory and quality compliance
• Responsible for ongoing compliance of the QMS and business practices related to sales, distribution, and supply chain operations with applicable regulations by highlighting and implementing regulatory requirements, driving improvement initiatives, and escalating issues to Senior Management where necessary
• Act as lead auditor for Internal and External audits for Hoya sites, distributors or suppliers
• Responsible for the design, approvals, and communication of HSOU annual audit program; responsible for the adequate, effective and proactive management of internal and external audits, according to approved audit plan
• Ensure timely registration of complaints in the Hoya Feedback Network, return of complaint samples, as well as effective customer communication regarding customer complaints
• Primary liaison for complaints and product quality related issues as well as field action in all the countries in the region.
• Manage HSOU CAPAs in an effective and timely manner
• Supports the business in solving issues with customers and distributors that relate to product quality
• Participate in the design, development, and maintenance of quality KPIs and dashboards, in collaboration with the global team

Education

• Bachelor’s degree in the fields of technology, healthcare, or Sciences

Experience

• 5 - 10 years of experience in management of quality systems in a regulated environment, preferably at least 5 years of experience in the field of medical device quality systems (acc.to ISO 13485, Medical Device Directive 93/42/ECC)
• Practical experience in performing internal audits; Experience in medical device vigilance with respect to the USA and Latin America.

Skills

• Solid people and project management skills; Good analytical and technical writing skills
• Good sense of supply chain and distribution will be a plus
• Ability to communicate technical medical device information
• Proficient at process mapping, flowcharting, databases/ systems, Excel, and other Microsoft Office tools
• Fluent in English and good command of Spanish and/or Portuguese due to required liaison with colleagues, vendors, etc. from South America
• Able to work in an international environment

Travel Requirement

• Up to 10%, mainly within the region

Work Conditions

• Position based in normal office environment with occasional travel across the region. Able to work within a fluid and dynamic international environment