Quality Assurance Engineer

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.