Overview
Quality Engineer Jobs in California, United States at Intellectt Inc
Title: Quality Engineer
Company: Intellectt Inc
Location: California, United States
Job Title: Quality Engineer (Contract, W2)
Location: CA, USA
Duration: Long-term (12+ months)
Key Responsibilities:
Perform quality assurance activities to ensure that medical devices meet regulatory and customer requirements.
Develop, review, and implement quality systems in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations and standards.
Lead and participate in the design control process, ensuring all aspects of product development comply with quality system requirements.
Conduct risk assessments and failure mode effects analyses (FMEA) for medical device products.
Review and approve product and process documentation including Device Master Records (DMR), Device History Records (DHR), and Design History Files (DHF).
Conduct root cause analysis (RCA) and corrective and preventive action (CAPA) investigations for non-conformances, customer complaints, and other quality issues.
Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory, etc.) to resolve quality issues and drive process improvements.
Perform product and process validation activities including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
Review and approve change control requests and impact assessments for design, process, and software changes.
Support supplier quality management activities including supplier audits, supplier performance monitoring, and ensuring that suppliers meet required quality standards.
Prepare for and support FDA inspections, ISO audits, and other external regulatory audits.
Maintain up-to-date knowledge of industry trends, regulations, and standards.
Ensure compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and other relevant guidelines.
Ensure that all product and process changes are appropriately documented and compliant with applicable regulations and standards.
Review and approve product testing protocols and reports, ensuring they meet regulatory and customer expectations.
Provide quality engineering support to ensure proper documentation, execution, and maintenance of quality systems.
Qualifications:
Bachelor’s degree in Engineering, Life Sciences, or a related field.
3+ years of experience as a Quality Engineer in the medical device industry.
Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and other relevant medical device regulatory standards.
Experience with product development and design controls for medical devices.
Familiarity with risk management tools such as FMEA, risk assessments, and hazard analysis.
Experience with root cause analysis (RCA), corrective and preventive action (CAPA) processes, and non-conformance management.
Strong understanding of statistical analysis and methods (e.g., process capability, design of experiments).
Experience with medical device validation, including IQ/OQ/PQ and process validation.
Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams.
Proficient with quality management systems (QMS) software and MS Office tools (Excel, Word, PowerPoint).
Knowledge of supplier quality management practices and conducting supplier audits.
Ability to work independently, manage time effectively, and prioritize tasks.
Familiarity with software validation and electronic records management systems (e.g., Veeva, MasterControl) is a plus.
