Job Information
Actalent Design Quality Engineer in New Berlin, Wisconsin
Job Title: Design Quality EngineerJob Description
Our client is seeking a highly skilled and detail-oriented Design QA Engineer to join our team. The ideal candidate will be responsible for ensuring the quality and compliance of our medical device designs throughout the development lifecycle. This role requires a strong understanding of medical device regulations, design control processes, and quality assurance methodologies. Key Responsibilities: - Collaborate with design and development teams to ensure compliance with regulatory standards (e.g., FDA, ISO). - Develop and implement design verification and validation plans. - Ensure that designs are manufacturable. - Participate in NPD and Tollgate and Design reviews. - Review and approve design documentation, including design inputs, outputs, and design history files. - Perform design reviews and audits to ensure adherence to quality standards. - Investigate and resolve design-related quality issues. - Manage and maintain Design History File Index. - Support supplier qualification activities if needed.
Hard Skills
Design Review/Verification Experience
Ability to interpret and understand drawings
In-depth knowledge of FDA regulations (FDA 21 CFR 820.30 & ISO 7.3)
3+ years in manufacturing environment
Soft Skills
Detail-oriented
Strong collaboration skills
Problem-solving abilities
Job Type
This is a contract position with a duration of 6 Month(s).
Work Site
This is a fully on-site position in New Berlin, Wisconsin.
Work Environment
Office setting, M-F first shift 8am-5pm
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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