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Quality Engineer (Medical Devices)
Contract : Des Plaines, Illinois, US
Salary Range : 40.00 - 45.00 | Per Hour
Job Code : 358191
End Date : 2025-03-02
Days Left : 11 days, 2 hours left
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Job Description : Position Summary :
The Quality Engineer, Quality Assurance will play a key role in supporting cross-functional teams through changes to on-market product design and manufacturing processes. This position also provides quality and compliance support for design control activities and regulatory requirements within the division. The ideal candidate will be a problem-solver with a deep understanding of quality systems and regulatory standards in the healthcare industry.
Key Responsibilities :
Cross-Functional Support & Problem-Solving
Act as a Quality Assurance (QA) representative on cross-functional teams, ensuring compliance with internal and external quality standards.Design Control & Change Management
Guide and influence cross-functional teams through design, validation, and regulatory compliance processes.Assess manufacturing process changes and their impact on product performance and regulatory compliance.Develop and document justifications for changes, considering crucial parameters and interdependent systems or products.Ensure robust alignment of product design with customer requirements throughout the design control lifecycle (inputs, verification, validation, and commercialization).Apply knowledge of IVDR standards (if applicable) to design and development processes.Quality System & Regulatory Compliance
Maintain compliance with site-level Quality Management System (QMS) policies and procedures.Ensure adherence to ISO, FDA, IVDR, and other regulatory standards relevant to medical device design and manufacturing.Support quality audits, CAPA (Corrective and Preventive Action) processes, and risk management initiatives.Assist in continuous improvement efforts to enhance product quality, process efficiency, and regulatory compliance.Qualifications & Experience :
Education : Bachelor's degree in Life Sciences, Engineering, or a related discipline (advanced degree preferred).Experience :5 years of experience in Quality Assurance, Regulatory Compliance, or a related field (diagnostic quality, technical areas, etc.).Experience in the Healthcare, Medical Device, or Diagnostic industries is strongly preferred.Hands-on experience with assay development or assay support is a plus.Technical Skills :Strong knowledge of design control principles, risk assessment, and validation strategies.Familiarity with ISO 13485, FDA , QSR, IVDR, and related regulatory frameworks.Experience with manufacturing process changes and impact assessments.Proficiency in data analysis, root cause investigations, and process improvement methodologies.Key Competencies :
Strong problem-solving and analytical skills with the ability to develop effective, compliant solutions.Excellent verbal and written communication skills; ability to influence and collaborate across teams.High attention to detail with a proactive approach to quality and compliance.Ability to manage multiple projects in a fast-paced and regulated environment.Pay Range : $40 / hr. - $45 / hr.
Job Requirement
CAPAMedical DevicesDesign ControlRoot cause investigationsProcess ImprovementFDA / ISOIVDRReach Out to a Recruiter
RecruiterEmailPhoneVishnu Nairvishnu.nair@collabera.comApply Now
Salary : $40 - $45
