Engineer for Quality, Verification & Validation (Medical Devices)

Engineer for Quality, Verification & Validation (Medical Devices)

Engineer for Quality, Verification & Validation (Medical Devices)

Williamsburg, VA

WEINERT Fiber Optics, Inc. is one of the nation's best designers and producers of high-quality fiber optic products. We serve well-respected manufacturers and other industrial and military players across various applications such as metrology, high-power and medical lasers, as well as industrial data transmission.

We are looking for a motivated quality engineer to join our team at the Williamsburg, VA site reporting directly to our Director of Quality, Regulatory & Compliance who will be working closely with Engineering, Manufacturing, and Purchasing to develop and ensure the highest quality standards of our products, SOPs, and Quality Management System.

Tasks and Responsibilities :

• Collaborate with our medical devices' design and development teams on regulatory strategy, verification and validation protocols, quality monitoring, and audit reports
• Support day to day manufacturing activities such as product inspection, review and approval of work instructions, customers' quality requirements, internal Standard Operating Procedures (SOPs), risk assessments, process tryouts, change control, and first article inspections (FAI)
• Improve assembly and inspection procedures to reduce and prevent defects
• Act as customer liaison with regards to quality complaints and resolution, and drive 8D reports
• Work with suppliers on corrective actions
• Review and perform as necessary root cause analysis, and identify and implement corrective actions
• Perform and support internal and external quality audits, track and report on Quality-related KPIs and statistics
• Maintain on-site measurement devices and oversee selected preventive maintenance actions
• Help implement quality- and regulatory-related software systems
• Other tasks as assigned by supervisor

Qualifications :

3 years of experience in a quality or industrial role in medical devices manufacturing

6 years of work experience in relevant roles will be considered

We are an equal opportunities employer and welcome applications from all qualified candidates.

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