Medical Device Quality Assurance Specialist

1 week ago

Staunton, Virginia, United States Cadence Inc Full time

Cadence Inc is seeking a highly skilled Medical Device Quality Assurance Specialist to ensure the highest standards of quality and compliance throughout our manufacturing processes. As a key member of our quality team, you will be responsible for ensuring that all products are manufactured and delivered according to the strictest quality standards. This includes maintaining the quality management system (QMS), leading validation efforts, and driving continuous improvements in quality processes.

Key Responsibilities:
  • Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant quality standards by coordinating internal and external audits, including supplier audits and regulatory inspections.
  • Lead Corrective and Preventive Actions (CAPA) to address non-conformances and ensure timely closure of quality events.
  • Support continuous improvement projects to enhance manufacturing processes, reduce defects, and improve overall product quality by conducting root cause analysis and developing corrective actions.
  • Lead and prepare protocols and reports for validation work, coordinate validation activities with affected departments and personnel, and provide oversight and leadership of process validation status and revalidation activities.
  • Qualify and manage suppliers, ensuring that raw materials and components meet required specifications for medical device manufacturing, perform supplier audits, and work with vendors to resolve quality-related issues.
  • Prepare and review technical documentation, including protocols, validation plans, work instructions, and Standard Operating Procedures (SOPs), and ensure all documentation is maintained in compliance with applicable regulations and that records are accurate and traceable.
  • Track and report on key quality metrics, including defect rates and audit findings, and provide quality training to staff on cleanroom operations, regulatory compliance, and quality standards.
Requirements:
  • Bachelor's degree in Engineering or related field.
  • Minimum of 3-5 years of experience in quality engineering or related roles within the medical device industry.
  • Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant quality standards.
  • Experience with risk management methodologies (e.g., FMEA, FMECA) and statistical analysis techniques.
  • Proficiency in quality tools and methodologies, such as root cause analysis, CAPA, process validation, statistical analysis, and GD&T.
  • Excellent communication, problem-solving, and interpersonal skills.
  • Ability to work effectively in a fast-paced, team-oriented environment.
  • Willingness and ability to work primarily onsite. Relocation package offered.

The estimated salary for this position is between $80,000 - $110,000 per year, depending on experience. We offer a competitive benefits package, including health insurance, retirement plan, and paid time off. If you are a motivated and experienced quality professional looking to take your career to the next level, please apply today

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