Oxenham Group
Complaints Investigator
Oxenham Group, Mansfield, Massachusetts, us, 02048
Job Overview:
We are seeking a detail-oriented and experienced Contract Medical Device Quality Engineer to join our team. The primary responsibility of this role is to address and resolve a backlog of customer complaints related to our medical devices. This position requires a thorough understanding of regulatory requirements, quality assurance processes, and excellent analytical skills.
Essential Duties and Responsibilities:Lead thorough investigations into customer complaints for Class I-III devicesEnsure all complaint investigations are conducted in accordance with FDA, ISO 13485, and other applicable regulations.Perform detailed root cause analysis and collaborate with cross-functional teams to identify corrective and preventive actions (CAPA).Document and report findings in accordance with FDA regulations, ISO standards, and internal quality management systems.Communicate investigation results to internal stakeholders and provide recommendations for product improvements.Ensure timely closure of complaints and adherence to all regulatory requirements.Minimum Qualifications:
Bachelor's degree in Engineering, Life Sciences, or a related field.3+ years of investigation experience5+ years of medical device experienceExperience working in a Lean or Six Sigma EnvironmentAbility to be on-site daily
We are seeking a detail-oriented and experienced Contract Medical Device Quality Engineer to join our team. The primary responsibility of this role is to address and resolve a backlog of customer complaints related to our medical devices. This position requires a thorough understanding of regulatory requirements, quality assurance processes, and excellent analytical skills.
Essential Duties and Responsibilities:Lead thorough investigations into customer complaints for Class I-III devicesEnsure all complaint investigations are conducted in accordance with FDA, ISO 13485, and other applicable regulations.Perform detailed root cause analysis and collaborate with cross-functional teams to identify corrective and preventive actions (CAPA).Document and report findings in accordance with FDA regulations, ISO standards, and internal quality management systems.Communicate investigation results to internal stakeholders and provide recommendations for product improvements.Ensure timely closure of complaints and adherence to all regulatory requirements.Minimum Qualifications:
Bachelor's degree in Engineering, Life Sciences, or a related field.3+ years of investigation experience5+ years of medical device experienceExperience working in a Lean or Six Sigma EnvironmentAbility to be on-site daily