Senior Manager of Quality Engineering (Medical Device)

Conteúdo do emprego

Our client is looking for a Quality Engineering Sr. Manager that will report to the Sr. director of QA and will be responsible for driving quality engineering in Taiwan operation.

The position will be responsible to ensure that good quality engineering practices are used from the design phase to the transfer into production ensuring compliance to Good Manufacturing Practice (CGMP), Quality System Regulation, 21 CFR Part 820. ISO 13485, ISO 14971, Medical Device Regulation (MDR) and other applicable standards.

Main Responsibilities

The (Sr.) manager of Quality Engineering is responsible for quality engineering activities related to new, existing or improved products and processes, and interactions with all functions to achieve goals and provide required support in the product, process or test method development.

These includes design assurance, design transfer, inspection planning, validation and risk management activities to ensure that the development and or manufacturing of medical devices is in compliance with company policies and procedures.

General Functions

• Ensures that goals and objectives are aligned with site strategic plan
• Ensures that owned processes comply to internal and external requirements
• Performs regular analysis over nonconformance and other quality indicators and triggers required actions in her or his area
• Governance and Support for: Design control activities; Design transfers; Validation activities for new and or existing processes, test methods and assembly equipment; Risk management
• Oversees the development of risk-based sampling plans for internally and externally produced products

This is not an exhaustive list of duties or functions and may change according to company needs.

Skills

and Qualification

• Master’s degree in materials science and engineering, or related disciplines
• Minimum 10 years of experience in Quality Engineering Function in medical device or regulated industry, with people management experience
• Expert knowledge of ISO click apply cGMP, FDA 21 CFR 820, 21 CFR part 11, ISO click apply ICH Q9, etc.
• Hands on experience with BS EN click applyA1:2020 “Medical Devices-Application of Usability Engineering to Medical Devices” and AAMI’s ANSI/AAMI HE75: 2009’s (R2018) “Human Factors Engineering-Design of Medical Devices
• Sound experience with implementation of a variety of technologies. Examples may include software, injection moulding, sterilization, cleanroom, etc.
• Innovative mind-set to upgrade the validation (methodology), metrology and risk management
• Proven record in continuous improvement, such as strategies to improve outcomes and efficiencies of V&V methods and automated testing tools
• Demonstrated problem-solving and troubleshooting skills
• Ability to recognize and prioritize quality issues
• Able to lead and drive changes
• Enjoys working in multi-cultural environment
• Fluent English