The Senior Quality Engineer will provide quality engineering support to Minnetonka manufacturing areas, specifically assuring the safety and performance of AMS products, the capability of the manufacturing processes, and compliance to quality system procedures and external regulatory requirements.
The Senior Quality Engineer develops, educates, practices, and promotes quality principles throughout the organization to achieve defined customer quality requirements and required regulatory compliance. In addition, this individual provides leadership and guidance to the organization to maintain compliance with QSR and ISO certification. This position is responsible for practicing all quality procedures and complying with all company policies.
All positions are responsible for following applicable AMS policies and procedures as defined by their manager.
· Provide manufacturing support, including nonconformance management, problem solving, root cause investigations, and solution development/implementation.
· Lead and support ongoing improvement and corrective action activities. Assist with data collection and ongoing analysis of data to drive improvements.
· Provide leadership to mobilize people to perform tasks.
· Monitor multiple sources of quality data for trends and potential issues.
· Analyze proposed manufacturing, design, and supply changes and determine appropriate revalidation / re-verification requirements.
· Provide technical assistance for incoming inspection and manufacturing quality problems.
· Lead and support risk management activities (dFMECA, FTA, pFMEA, etc).
· Support internal audit activities.
· Coordinate with other quality functions as needed (i.e. Supplier Qualifications, Microbiology, Sterilization, etc).
· Promote the use of best-practice quality and statistical tools.
· Bachelor’s degree in engineering or science–related fields.
· 5-10 years experience in medical device industry.
· Strong background in statistical techniques, measurement tools and SPC tools.
· Thorough knowledge of QSR and ISO quality system requirements.
· Knowledge of process validation, IQ/OQ/PQ.
· Demonstrated use of logic, analytical and technical skills to solve complex problems with effective solutions. Solid leadership and organizational skills.
· Proven ability to collaborate with teams while assuring compliance.
· Strong verbal communication / presentation skills.
· Strong technical writing skills with an attention to detail.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.