Service Quality Engineer
Fusion Life Scienceswinterthur, DE
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Job Description
Position: Service Quality Engineer Duration: 12 month contract On-site in Newark DE
Key Responsibilities: Support remediation activities addressing service-related quality gaps identified through audits, inspections, or internal assessments. Review and remediate service procedures, work instructions, and documentation to ensure compliance with regulatory requirements and quality standards. Assess and improve service documentation practices, including service reports, maintenance records, and device history documentation. Conduct gap assessments of service processes against applicable medical device regulations and quality standards. Develop and implement corrective and preventive actions (CAPAs), NCEEs, process documentation related to service of device. Assist with strategy planning of preventative maintenance for service of manufacturing equipment from a quality perspective. Support remediation of complaint handling and service investigation processes, including root cause analysis and documentation improvements. Collaborate with cross-functional teams to ensure alignment between service operations, quality systems, and regulatory requirements. Assist in strengthening technician training, qualification, and competency documentation related to equipment and device services. Prepare documentation, evidence packages, and reports to support regulatory responses, remediation tracking, and audit readiness.Required Qualifications: Experience working in the quality department at a medical device company specifically on the service side of the business versus the product side of the business. Strong knowledge of ISO 13485 requirements. Background with Lean Six Sigma initiatives and OSHA requirements related to quality engineering in medical device. Previous experience working on CAPAs, deviations, and NCEEs related to servicing of the device and equipment. Experience supporting quality remediation projects, regulatory observations, or inspection readiness initiatives. Demonstrated experience with CAPA, root cause analysis, and process improvement. Strong documentation and technical writing skills for regulated environments.
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FAQs About Service Quality Engineer Jobs at Fusion Life Sciences
What is the work location for this position at Fusion Life Sciences?
This job at Fusion Life Sciences is located in winterthur, DE, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Fusion Life Sciences?
Employer has not shared pay details for this role.
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