Demo

Qms specialist

JBL Resources
Portage, MI Full Time
POSTED ON 1/27/2025
AVAILABLE BEFORE 2/22/2025

QMS Integration Engineer

Location : Kalamazoo, Michigan (Hybrid)

About Our Client :

Accepting no less than the absolute best, our client has climbed to the top, gaining a reputation for both excellence and satisfaction.

Working at this company will give you the opportunity to work with some of the top technical professionals in the industry who are bringing cutting-edge products to forefront.

Offering results-driven people a place where they can truly make a difference on a daily basis, this is an opportunity you will not want to miss!

Key Responsibilities :

149; Coordinating and preparing document packages for regulatory submissions from all areas of the organization.

149; Collecting all materials required in submissions, license renewal, and annual registrations.

149; Keeping abreast of regulatory procedures and changes.

149; Interacting with regulatory agencies.

149; Working on problems of complex scope where data analysis requires evaluation of specific factors.

149; Utilizing independent judgment within broad parameters to determine an appropriate solution.

149; Determining methods and procedures on new projects and may provide guidance to other lower-level staff.

149; Integrating the Quality Management Systems (QMS) of the two organizations to ensure compliance with relevant industry standards and regulations.

149; Supporting the integration of quality systems between our company and the acquired organization, with a specific focus on regulatory and quality compliance for software / AI products.

149; Collaborating with cross-functional teams from both companies to align quality system policies, processes, and procedures, ensuring consistent and effective integration.

149; Assessing existing quality systems and developing integration plans that address gaps, with special attention to software / AI product requirements.

149; Supporting compliance with regulatory standards such as ISO 13485, 21 CFR Part 820, and other relevant regulations specific to software and AI in the medical device space.

149; Facilitating risk assessments and gap analyses to identify areas needing improvement or harmonization within the combined quality systems.

149; Ensuring alignment with post-market surveillance and product lifecycle requirements unique to software / AI products.

149; Providing regular status updates and integration metrics to stakeholders.

Qualifications :

149; Bachelor’s degree in Engineering, Life Sciences, or a related discipline.

149; Minimum of 2 or more years’ experience in Quality Systems management within the medical device industry, particularly with software or AI-driven products.

149; Strong understanding of regulatory standards, including ISO 13485, 21 CFR Part 820, and other applicable software / AI regulations.

149; Demonstrated experience in managing Quality System integrations post-acquisition.

149; Excellent communication and project management skills, with the ability to work cross-functionally and facilitate effective collaboration between teams.

149; Ability to analyze complex Quality System structures and recommend practical integration strategies.

149; Experience in Software Development Lifecyle (SDLC), Software as Medical Device (SaMD) and / or healthcare IT preferred.

149; NO C2C CANDIDATES

For more information about our services and great opportunities at JBL Resources, please visit our website : https : / / www.jblresources.com.

JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management.

As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.

JBL is an Equal Opportunity Employer and E-Verify Company

Last updated : 2024-11-23

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