Overview
Quality Assurance Engineer Jobs in United States at EPM Scientific
Title: Quality Assurance Engineer
Company: EPM Scientific
Location: United States
EPM Scientific are looking for 2 top level candidates to come onboard as a Quality Assurance Engineer with a medical device client of ours. Role responsibilities and details will be listed below.
W2 Contract
1-2 Years
Hybrid – 2 days On Site (Philly based)
Responsibilities:
Develop, implement, and maintain quality assurance protocols and procedures to ensure compliance with industry standards and regulatory requirements (e.g., FDA, ISO 13485).
Conduct thorough inspections and audits of manufacturing processes, products, and systems to identify areas for improvement and ensure adherence to quality standards.
Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to address quality issues and implement corrective actions.
Perform root cause analysis and implement corrective and preventive actions (CAPA) to resolve quality-related issues.
Prepare and review documentation, including quality plans, validation protocols, and test reports, to ensure accuracy and completeness.
Participate in risk management activities, including failure mode and effects analysis (FMEA) and hazard analysis.
Provide training and support to staff on quality assurance processes and best practices.
Stay current with industry trends and advancements in quality assurance methodologies and regulatory requirements.
Qualifications:
Bachelor’s degree in Engineering, Life Sciences, or a related field.
Minimum of 5 years of experience in quality assurance within the medical device industry.
In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards.
Strong analytical and problem-solving skills, with a keen attention to detail.
Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
Proficiency in quality management software and tools.
Certification in quality assurance (e.g., ASQ CQE) is a plus.
