Bachelor's degree in Engineering, Science, Mathematics, or related field.
2-5 years of Quality Engineering experience in medical device or pharmaceutical sectors.
Strong understanding of FDA regulations (21 CFR Part 820) and ISO 13485 standards.
Hands-on experience with Design History Files (DHF) and Corrective and Preventive Actions (CAPA).
Knowledgeable in risk management, supplier quality, and compliance activities.
Proficient in statistical process control (SPC) and process improvement methodologies.
Strong analytical, problem-solving, and communication skills.
Responsibilities
Provide quality support for Product Development and Quality Management Systems (QMS).
Ensure compliance with FDA 21 CFR Part 820 and ISO 13485 during remediation projects.
Collaborate with suppliers to resolve quality issues and manage vendor programs.
Lead investigations into non-conformances and implement corrective action plans.
Review design and quality documents for regulatory compliance.
Support continuous improvement initiatives to enhance product quality.
Design and conduct product testing and data analyses for reliability improvements.
Benefits
Opportunity to work in a regulated medical and pharmaceutical environment.
Collaboration with cross-functional teams and external laboratories.
Exposure to diverse projects including remediation and compliance.
Professional growth opportunities in quality management and engineering.
Engagement in continuous improvement practices.
Full Job Description
Job Summary:
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.
