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Quality Engineer
Job Summary:
Roles & Responsibilities:
Education & Experience:
- Quality Engineer / Quality Compliance Engineer with experience supporting remediation efforts and maintaining quality standards within regulated medical device, pharmaceutical, OTC drug, and cosmetic environments.
- Responsible for supporting Quality Management Systems (QMS), Design Controls, CAPA, Risk Management, supplier quality activities, process validation, and regulatory compliance while ensuring adherence to FDA and ISO quality standards.
Roles & Responsibilities:
- Provide quality engineering support for Product Development, QMS, Design Controls, Design History Files (DHF), CAPA, Risk Management, and CE Technical File activities.
- Support remediation projects and ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable domestic/international regulations.
- Collaborate with supplier representatives to resolve quality issues, implement CAPA/SCAR activities, and support supplier qualification and vendor management programs.
- Lead investigations related to product/process non-conformances, deviations, and out-of-specification (OOS) results, performing root cause analysis and corrective actions.
- Review design and quality documentation to ensure compliance with regulatory requirements and company standards.
- Support process control, process validation, testing, inspection, and continuous improvement activities to enhance product quality and manufacturing efficiency.
- Apply Statistical Process Control (SPC) methods and statistical analysis techniques to evaluate process performance and identify process variation trends.
- Design and execute product testing, data analysis, and failure investigations to minimize defects and improve product reliability.
- Coordinate product testing activities with internal teams and external laboratories.
- Develop and maintain Device Master Records (DMR), product specifications, validation documentation, and technical files in compliance with regulatory requirements.
- Support preparation of regulatory submissions including 510(k) documentation, letters to file, and other quality compliance documentation.
- Collaborate with cross-functional teams including Manufacturing, Regulatory Affairs, Quality Systems, and Suppliers to ensure quality-compliant project execution.
Education & Experience:
- Bachelor's degree in engineering, Science, Mathematics, or a related technical field.
- 2 5 years of Quality Engineering experience in Medical Device and/or pharmaceutical industries.
- Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and regulated quality system requirements.
- Hands-on experience with Device History Files (DHF), CAPA, Risk Management, supplier quality, and compliance activities.
- Experience supporting investigations, process validation, remediation projects, and quality system compliance in regulated environments.
- Knowledge of Design Controls, SPC, statistical analysis, process improvement methodologies, and validation activities.
- Strong analytical, problem-solving, communication, and documentation skills.
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