Job Title: Quality Engineer – Medical Device Industry
Location: Boston. MA
Job Summary:
We are seeking a detail-oriented and driven Quality Engineer to join our team in the medical device industry. The Quality Engineer will ensure that all products meet regulatory and quality standards, support continuous improvement initiatives, and ensure compliance with ISO 13485 and FDA regulations. This role requires strong problem-solving skills, excellent communication, and the ability to work collaboratively across multiple departments.
Key Responsibilities:
- Develop, implement, and maintain quality management systems in compliance with ISO 13485, FDA QSR, and other applicable standards.
- Conduct risk management activities, including Failure Mode and Effects Analysis (FMEA), to identify and mitigate product and process risks.
- Perform root cause analysis and implement corrective and preventive actions (CAPA) to address product and process issues.
- Plan and execute internal and supplier audits to ensure compliance with quality standards and regulations.
- Review and approve validation protocols and reports for processes, equipment, and software.
- Collaborate with cross-functional teams, including R&D, manufacturing, and supply chain, to ensure quality requirements are met throughout the product lifecycle.
- Monitor and analyze quality metrics, trends, and data to drive continuous improvement initiatives.
Qualifications and Skills:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- Minimum of 2-5 years of experience in quality engineering within the medical device industry.
- In-depth knowledge of ISO 13485, FDA QSR, and other relevant regulatory standards.
- Strong experience in CAPA, risk management, and validation processes.
- Proficiency in using quality tools such as statistical process control (SPC) and six sigma methodologies.
- Exceptional analytical and problem-solving skills.