Sr. Quality Systems Engineer - Impact Business Group : Job Details

Job Description Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Quality Systems Engineer for a 12 month + Contract . Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. Seeking a dedicated contractor to support integration activities between our existing company and a recently acquired company with a primary focus on integrating the Quality Management Systems (QMS) of the two organizations. Position Description (Principle Duties and Responsibilities)

• The Quality Engineer will provide expertise in the execution through the QMS to support the integration of the new acquisition through execution of QMS activities, review of artifacts, driving process and product changes through the change control process.
• The Quality Engineer will work closely with cross-functional teams including regulatory affairs, quality assurance and R&D to support the integration project.
• Drive the design control process to execute through the existing and new processes.
• Collaborate with the cross functional stakeholders on reviews with requirements, V&V, CSV, design documents.
• Drive safety risk assessment (sFMEA/Risk Plans)
• Support release management, DevSecOps processes to drive compliance.
• Create or review SOPs, work instructions, and forms

Job Requirements Requirements

• Proven experience in Quality Systems management within the medical device industry
• Strong understanding of regulatory standards, including ISO 13485, 21 CFR Part 820, and other applicable regulations.
• Demonstrated experience in managing Quality System integrations post-acquisition.
• Excellent communication and project management skills, with the ability to work cross-functionally and facilitate effective collaboration between teams.
• Ability to analyze complex Quality System structures and recommend practical integration strategies.
• This contractor role offers the opportunity to play a vital part in our organization's growth and innovation, ensuring a seamless and compliant integration of Quality Systems across both companies.