Design Quality Engineer II
About Your New Employer
Join a company at the forefront of medical device development, known for its commitment to quality and innovation.
Work on projects that have a significant impact on patient care worldwide.
Benefit from a collaborative and supportive work culture that values professional growth and development.
About Your New Job as Design Quality Engineer II
Represent quality interests and concerns on project teams, ensuring quality and risk management throughout the lifecycle of new product development (NPD) projects.
Lead risk management activities and own the quality engineering tasks for NPD projects, including UFMEA, DFMEA, PFMEA, and related documentation.
Review design control compliance requirements for NPD projects and all design elements.
Perform statistical analyses (e.g., DOE) to support product and process optimization or resolve causes of process variation, and initiate corrective actions as required.
Support biocompatibility testing aligned with ISO10993 and company procedures.
Participate in internal and supplier audit programs, and validate test methods and measurement systems like Gauge R&R.
What Skills You Need for Design Quality Engineer II
Third-level qualification in engineering, science, or a technical field.
Minimum of five years of experience in the medical device or pharmaceutical industries.
Solid understanding of regulatory standards, including ISO 13485, ISO 14971, and related CFRs.
Strong attention to detail and adaptability.
Excellent problem-solving abilities and organizational skills.
Strong interpersonal skills with the ability to work independently and collaboratively in team settings.
What's on Offer
Attractive compensation package.
Opportunities for training, development, and career advancement.
A supportive and dynamic work environment that values innovation and excellence.
What's Next
Apply now by clicking the "Apply Now" button or call me, Karolina, on .
If the job isn't quite right but you are looking for something similar, please get in touch.
We also have multiple Temp, FTC, and Contract jobs available.
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