Job Title: Quality Engineer I
Location: Des Plaines, IL 60018
Key Responsibilities :
- Provide solutions to complex problems while ensuring compliance, innovation, and practicality, aligned with organizational objectives.
- Act as a QA representative on cross-functional project teams, collaborating with employees, managers, and peers.
- Communicate effectively with management, peers, and key stakeholders, ensuring clarity and confidence in all interactions.
- Guide and influence on-market product teams through design, validation, and regulatory compliance to ensure products meet customer requirements.
- Assess the impact of manufacturing process changes on product quality and develop justifications for modifications, considering crucial parameters and affected systems.
- Apply a thorough understanding of the design control lifecycle, including design inputs, verification, validation, and commercialization.
- Ensure compliance with relevant quality systems for medical device(s), including adherence to site-specific policies and procedures.
Qualifications :
- Education : Bachelor’s degree in Life Sciences, Engineering, or a closely related field.
- Experience : Minimum 5 years of experience in Quality or a related field (e.g., diagnostic quality, technical areas). Less experience may be acceptable with an advanced degree.
- Preferred : Experience in the healthcare industry, particularly in assay development or support, and knowledge of IVDR standards as applied to design processes.
Skills and Competencies :
- Strong understanding of design control processes, including verification, validation, and commercialization.
- Ability to assess process changes and their impact on product quality.
- Proven ability to collaborate effectively with cross-functional teams and stakeholders.
- Knowledge of relevant regulatory and quality standards for medical devices.