What are the responsibilities and job description for the Quality Assurance Engineer position at Caliberr Staffing?
About the Role
As a Quality Assurance Engineer, you will play a pivotal role in ensuring product excellence by overseeing quality design controls and risk management throughout the entire product development lifecycle. You will drive continuous improvement initiatives and collaborate with cross-functional teams to maintain rigorous compliance standards in a high-precision manufacturing environment.
Responsibilities- Design and execute comprehensive quality plans to ensure product integrity from development through distribution.
- Lead risk management activities and process master validation strategies to meet project-specific requirements.
- Develop and validate test methods to ensure accurate measurement of product effectiveness and performance.
- Implement robust inspection protocols for incoming materials, in-process components, and final product release.
- Represent quality engineering in design reviews and provide technical guidance on characterization requirements.
- Conduct supplier audits and assessments to ensure vendor compliance with quality standards.
- Apply systematic problem-solving methodologies to identify, prioritize, and resolve quality-related issues.
- Foster a culture of quality by ensuring adherence to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
Required Skills
- Bachelor’s degree in Engineering, Quality, or a related technical field, or equivalent industry experience.
- 2-5 years of experience in a regulated manufacturing environment, such as medical devices, aerospace, or pharmaceuticals.
- Strong working knowledge of ISO 13485, 21CFR 820, and EU MDR standards.
- Proficiency in statistical analysis, process capability, and GD&T.
- Experience with First Article Inspections and component qualification processes.
Preferred Skills
- Professional certification such as ASQ CQE or similar quality credentials.
- Proven ability to support and lead external regulatory or customer audits.
- Excellent communication skills with the ability to collaborate effectively across R&D and manufacturing teams.
- Experience developing Quality Agreements for external partnerships.
Salary : $37 - $58