Quality Engineer - Burlington, United States - Precision Life Sciences

Precision Life Sciences Burlington, United States

1 week ago

Description

Job Description:
Quality Engineer

The Quality Engineer will support sustaining engineering and new product development activity for the Quality Assurance department in a dynamic and complex engineering environment.

RESPONSIBILITIES
Support sustaining engineering through operational quality activity - material control, process development, inspection/acceptance activity, nonconforming material control, equipment qualification, and supplier management
Participate in risk management activity - analysis and documentation applied throughout the product development process
Inspect and test materials, equipment, processes, and products to ensure quality specifications are met
Support test method development and qualification activity
Support the design engineering teams for catheter, hardware, and systems throughout the design control process
Design and implement quality system processes to comply with regulatory standards

SKILLS AND EXPERIENCE
Degree in mechanical or biomedical engineering or related applicable engineering field
3-5 years of experience in quality engineering, quality assurance, or a related role in a regulated industry
Experience in catheter, hardware, and system production, or with similar medical devices, while working with a Quality Management System
Applied understanding of 21 CFR 820 and ISO 13485:2016
Demonstrated expertise in Process Validation, Product Validation, and Statistical Methods
Experience in risk management and design control
Excellent communication skills, good documentation practices (formal protocols and reports), attention to detail, and project management skills

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