About this opportunity
Judge Direct Placement lists this Quality Systems Manager - Medical Device/Tooling opportunity in morris county, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Our client is currently seeking a Medical Device Quality Systems - Tooling
Bachelor’s degree in Engineering, Quality, or related field.
Demonstrated years of experience in medical device manufacturing quality systems, with direct ownership of QMS processes.
Demonstrated experience implementing ISO 13485 and successfully achieving certification.
Hands-on experience completing FDA Establishment Registration
Strong working knowledge of 21 CFR Part 820, ISO 13485, and applicable regulatory guidance.
Proven success leading internal and external audits.
Excellent communication, documentation, and cross-functional leadership skills.
Experience in injection molding, assembly, machining, or other precision manufacturing environments.
ASQ certifications (CQE, CQA, CMQ/OE) or equivalent.
Familiarity with electronic QMS platforms.
Full Benefits with Healthcare etc
#JDP
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.