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.
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