Senior Manager of Quality Engineering

Contenido de trabajo

About the Job

SHL Medical AG is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018.

Taiwan has been SHL’s starting ground in our bid for global mobility in the fields of drug delivery and medical technology. Our ambitious people who come from various cultures share the same aspiration – ensuring the right drug device for the delivery of modern precision medicine.

Job Overview/Objective

The company 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

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 13485:2016, cGMP, FDA 21 CFR 820, 21 CFR part 11, ISO 14971:2019 & ICH Q9, etc.
• Hands on experience with BS EN 62366-1:2015+A1:2020 “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
• Strong organizational, analytical and time-management skills
• Ability to recognize and prioritize quality issues
• Able to lead and drive changes
• Enjoys working in multi-cultural environment
• Fluent English

Below streaming are aimed to help you understand more about SHL medical TW, please visit:

• SHL experiencehttps://youtu.be/0bg7qJfS1hA
• The shape of better injection:https://www.youtube.com/watch?v=7-_KDAIF59w
• The making of autoinjectorhttps://www.youtube.com/watch?v=wRud0cnDHZ8

We offer

• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization
• Competitive compensation package

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including CV and all other relevant documents.

For more information on SHL Medical, please visit our website: www.shl-medical.com

Is this not quite what you are looking for? Further interesting career opportunities can be found on our SHL Career page: www.shl-medical.com/careers