Senior Quality Engineer

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

A mid-senior level Quality Engineering personnel who applies scientific knowledge, engineering knowledge, and ingenuity to lead quality assignments related to medical device manufacturing. The candidate ensures consistent implementation and compliance to external regulations including, but not limited to FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 11608 & ISO 14971.

Main Responsibilities

• Represent QA in design review meetings to review all quality aspects of new products. Work with Design & Product Development Engineers to ensure quality considerations during design and concept stage.
• Assess and approve the risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls – UFMEA, DFMEA, PFMEA.
• Review and coordinate with Validation for all test method and design validations.
• Provide input for product lifecycle through:

• Additional Responsibilities May Include:

Required Skills & Qualifications

• Degree in Life Science or Engineering discipline with a minimum of 5 years of experience in the medical device, pharmaceutical or biotechnology industry.
• Experience in providing quality engineering leadership to project teams in the areas of Design Controls, Process Validation, and Risk Management.
• Experienced with New Product Development.
• Demonstrate use of Quality tools/methodologies. Good knowledge of FDA, GxP, ISO 13485, and ISO 14971.
• Demonstrated and applied a broad knowledge of field of specialization through successful completion of moderately complex assignments.

We offer

• Competitive compensation package.
• Modern & variety of culture 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.

Apply for this Job

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

Please note: For this position we do not consider applications from recruitment agencies.