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Quality Engineer (Medical Devices Industry Experience required), Contract-to-Hire

Quality Engineer (Medical Devices Industry Experience required), Contract-to-Hire

FlexStaff CareersSavannah, GA, US
22 hours ago
Job type
  • Full-time
Job description

Job Description

FlexStaff is seeking a Quality Engineer with experience in Medical Device manufacturing to work with one of our clients, a leading global distributor of healthcare products and services for their manufacturing division in Savannah, GA.

This is a contract-to-hire job.

Schedule : Monday to Friday, 8 : 00 AM - 5 PM (100% on-site)

What You'll Do :

  • Develop and implement systems to ensure products and / or services are designed and produced to meet or exceed customer expectations and regulatory requirements, including the US Food and Drug Administration, Health Canada, European MDD / MDR.

Minimum requirements :

  • Three (3) or more years of experience in product engineering, manufacturing engineering and / or quality engineering within the Medical Device Industry.
  • A Bachelor's Degree in engineering
  • Strong working knowledge of medical device regulations including 21CFR820, MDD, MDR
  • and other global regulatory requirements and quality system standards including ISO14971, IEC 60601 and other relevant standards.

    • Your responsibilities will include :

  • Continuous Improvement : Identify and recommend enhancements in product design and manufacturing processes. Provide quality engineering support for risk management, design changes, and CAPA investigations.
  • Quality System Expertise : Author, review, and approve Quality System documentation, including NCMR and Engineering Change Control.
  • Supplier Quality Improvement : Drive supplier quality through engineering analysis and root cause investigations. Collaborate with suppliers to reduce defects and improve yield.
  • Trend Analysis : Conduct periodic product and process trend analyses to ensure quality, patient safety, and regulatory compliance. Implement corrective actions and problem-solving methodologies to reduce defects.
  • Product Development Guidance : Offer quality engineering insights for product and process improvements, validating design inputs related to usability, reliability, safety, and manufacturability.
  • Quality Control Planning : Assure product quality in line with best practices, including material control and process validation, based on risk management outcomes.
  • Validation and Testing : Author validation and inspection assessments to ensure product release readiness. Select tests and sampling sizes based on criticality.
  • Regulatory Compliance : Stay updated on relevant quality standards (e.g., Medical Device Directive, US FDA) and adapt quality processes to meet changing requirements.
  • Computer System Validation : Perform computer system validation and ensure adherence to regulatory standards.
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    Quality Engineer • Savannah, GA, US