Manager Quality Assurance, QA R&D

The Manager Quality Assurance acts as an advocate for product safety, quality, and efficacy, and will maintain compliance of the QMS.

This position is responsible to ensure that products meet quality goals and regulatory requirements, including but not limited to FDA Quality System Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971.

He/She must ensure that all required validations, including test method validations, equipment qualifications & calibrations are performed, compliant, and the needs of regulatory submissions are fulfilled. The implementation of the comprehensive risk management process during the developing phase of the product life cycle is required to provide safe products to global markets.

Key duties and responsibilities

• Work with HOYA Surgical Optics (HSO) R&D teams in different countries to ensure that design control is completed in accordance with procedures, WI, regulatory requirements, and to assure that required outputs have been completed
• Conduct risk management for devices, processes, and provide the assessment results from product development through to the launch
• Establish risk management files with the Global R&D/ME team to support product development (including – Risk Management Plans, Risk Control Log, Benefit Risk Assessment Risk Management Report, xFMEA, etc.), and act as the Risk Management expert
• Assist in the development and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports, and design transfer
• Work with project teams to ensure the validation master plan captures all validations / requirements required for global submissions
• Work with project teams to generate and maintain design history files and index through product lifecycle
• Review and approve design verification test protocols, reports and data from a logical point of view (rationale, objectiveness and statistics)
• Ensure compliance of IQ, OQ, tests method validation and work instructions regarding product development
• Maintain QMS of the R&D USA site, and take charge of the USA R&D Site QA
• Prepare and host audits by competent authorities and notified bodies
• Perform internal audits at the local site, and other sites as required
• Review and approve other quality documents (e.g., IQ , OQ, PQ, WI, etc.) within areas of responsibility
• Manage and monitor the progress of the calibration and maintenance of testing equipment. to ensure calibration and maintenance records satisfy regulatory and QMS requirements (act as Equipment Control Administrator for the USA site)
• Support with the qualification of suppliers in USA in collaboration with Supplier quality team
• Participate in projects and change control request meetings to support the resolution of engineering issues
• Partner with the post-market surveillance team and complaints investigation teams to drive improvements for sustaining products, and establish risk management process throughout a product’s lifecycle
• Provide support for other quality activities and improvement initiatives, quality data collection and trending, CAPAs, change controls, training, etc.
• Support initiatives as identified by management to support Quality Management Systems (QMS) and other regulatory requirements

Education

• A bachelor’s degree or higher in Chemical, Bioengineering, Optical Engineering or related fields

Experience

• At least 5 years experience working as QA or R&D/ Laboratory Manager in Medical Device/ Pharmaceutical product or optical engineering business field
• Experience in test method validation
• Understand Risk Management (ISO14971 and/or ISO12100) and Quality System (any one of ISO13485, ISO17025, ISO9001and QS-9000)

Skills

• Business software skills (e.g. Word, Excel and Power point)

Travel Requirements

• Monthly (approximate) USA domestic travel, and 2-3 international travel annually mainly Singapore, Thailand, or Japan