Quality Engineer
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Job title: Quality Engineer
Location: Southington, CT
Duration : 12+ Months
Industry: Pharma
Key Responsibilities
Location: Southington, CT
Duration : 12+ Months
Industry: Pharma
Key Responsibilities
- Quality Systems Management: Maintain and improve the Quality Management System (QMS) to ensure compliance with ISO 13485, 21 CFR Part 820, FDA regulations, and other applicable standards.
- Product Development Support: Collaborate with the R&D and manufacturing teams to ensure quality is integrated into the product design and development process.
- Process Validation: Oversee validation activities for manufacturing processes, equipment, and software, ensuring compliance with validation protocols such as IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
- Risk Management: Conduct risk analysis and manage the risk assessment process (e.g., FMEA) to identify and mitigate potential quality issues in product development and production.
- CAPA (Corrective and Preventive Actions): Lead and participate in the CAPA process to address non-conformances, deviations, and other quality-related issues, ensuring root cause analysis and effective corrective actions are implemented.
- Internal & Supplier Audits: Conduct and participate in internal audits and external supplier audits to ensure compliance with quality and regulatory standards.
- Non-Conformance Management: Investigate non-conforming products and materials, perform root cause analysis, and implement corrective and preventive actions to prevent recurrence.
- Documentation & Reporting: Maintain accurate quality records, including inspection reports, validation documents, and regulatory submissions. Ensure documentation complies with QMS requirements.
- Continuous Improvement: Drive continuous improvement initiatives to enhance product quality, reduce defects, and improve manufacturing processes.
- Complaint Handling: Assist in the investigation of customer complaints and product returns, ensuring timely resolution and reporting of issues to regulatory authorities as required.
- Regulatory Compliance: Ensure all products and processes meet relevant medical device regulations, including FDA, EU MDR, and other global standards.
- Supplier Quality Management: Work with suppliers to ensure that incoming materials meet specified quality standards. Conduct supplier quality audits and manage supplier performance.
- Education:
- Bachelor’s degree in Engineering, Biomedical Engineering, Quality Engineering, or a related technical field.
- Certifications such as Certified Quality Engineer (CQE) or Six Sigma (Green Belt or Black Belt) are a plus.
- Experience:
- 3-5 years of experience in a quality engineering role within the medical device industry.
- Proven experience working with ISO 13485, FDA regulations (21 CFR Part 820), and other regulatory standards in the medical device field.
- Technical Skills:
- Experience with validation protocols (IQ, OQ, PQ) and process validation in a regulated environment.
- Proficiency in quality tools and methodologies, such as Root Cause Analysis (RCA), FMEA, SPC, and CAPA.
- Strong understanding of GMP (Good Manufacturing Practices) and risk management principles.
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