Quality Systems Engineer

Philips•Plymouth, MN

1d•Hybrid

About The Position

Support business and site level aspects of the quality management system for the Philips Image Guided Therapy Devices business. You will support sites within this business in continuous maintenance and improvement of the Quality Management System and its subsystems.

Requirements

Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
3+ years of experience in Quality Management Systems, Regulatory Compliance, Auditing with medical device or a regulated industry, preferred.
Proficiency in ISO 9001, ISO 13485, FDA CRF 21 part 820 and Good Manufacturing Practices (GMP).
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
For this position, you must reside in or within commuting distance to Plymouth, MN.

Nice To Haves

3+ years of experience in Quality Management Systems, Regulatory Compliance, Auditing with medical device or a regulated industry, preferred.

Responsibilities

Supporting and maintain Quality Management Systems to meet FDA 21CFR820 (QMSR), ISO13485, MDSAP, and other regulatory requirements as applicable for the site. Systems include (but not limited to): Change Management; Document and Record Control; CAPA; Audits; Training; Data Analytics and Trending; Management Review.
Support initiatives to drive simplification and integration of quality system requirements and business processes to ensure compliance and facilitate global business growth.
Support the respective QMS architecture and processes.
Support and sometimes execute change notices within the Document Controls system (Windchill) ensuring appropriateness and effectiveness.
Escalate areas of non-compliance, risk and/or potential improvement to Management and develop plans for appropriate action to address causes of deficiencies. Identify and investigate potential trends for improvement initiatives.