Quality Assurance Engineer

We have a current opportunity for a Quality Assurance Engineer on a contract basis.

Our client is a leading innovator in the medical device industry, dedicated to improving patient outcomes through cutting-edge technology and rigorous quality standards. They are seeking a talented Quality Assurance Engineer to join their dynamic team in Massachusetts.

Job Description:

Responsibilities:

• Develop, implement, and maintain quality assurance protocols and procedures to ensure compliance with industry standards and regulatory requirements.
• Conduct thorough inspections and audits of manufacturing processes, ensuring 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 issues.
• Participate in the design and development of new medical devices, providing quality assurance input to ensure product reliability and safety.
• Maintain and update quality documentation, including standard operating procedures (SOPs), work instructions, and quality records.
• Conduct training sessions for staff on quality assurance processes and best practices.
• Stay current with industry trends and regulatory changes to ensure ongoing compliance.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Minimum of 3-5 years of experience in quality assurance within the medical device industry.
• Strong knowledge of FDA regulations, ISO 13485, and other relevant quality standards.
• Experience with quality management systems (QMS) and tools such as CAPA, FMEA, and risk management.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
• Detail-oriented with a commitment to maintaining high-quality standards.