Quality Engineer

2 weeks ago

Staunton, United States Cadence Inc Full time

Cadence VA is looking for a dedicated Quality Engineer to ensure the highest standards of quality and compliance throughout our manufacturing processes. As a Quality Engineer for a Contract Medical Device Manufacturing Organization, you will be responsible for ensuring that all products are manufactured and delivered according to the strictest quality standards. You will work closely with manufacturing, engineering, and regulatory teams to ensure compliance with ISO 13485, FDA, and other applicable medical device regulations. Your role will involve maintaining the quality management system (QMS), leading validation efforts, and driving continuous improvements in quality processes.

Why should you choose Cadence?

  • Shape the Future of Healthcare: Join a team dedicated to producing cutting-edge medical devices that advance patient outcomes and revolutionize healthcare delivery worldwide.
  • Challenge Yourself: Take on exciting challenges and solve complex problems as you navigate the dynamic regulatory landscape and continuously improve quality practices in a fast-paced manufacturing environment.
  • Be a Leader in Quality Excellence: Lead the charge in furthering our reputation for excellence by implementing best-in-class quality systems and driving continuous improvement initiatives across our manufacturing operations.
  • Be Part of Something Meaningful: Join a company that is committed to making a positive impact on people's lives, where your contributions as a Quality Engineer play a vital role in ensuring the safety and efficacy of medical devices that save lives every day.
Key Responsibilities:
  • Quality Management System (QMS):
    • Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards.
    • Coordinate and support 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.
  • Process Improvement:
    • Support continuous improvement projects to enhance manufacturing processes, reduce defects, and improve overall product quality.
    • Conduct root cause analysis to investigate quality issues and develop corrective actions to prevent recurrence.
  • Process Validation:
    • Lead and prepare protocols and reports for validation work.
    • Coordinate validation activities with constant communication with affected departments and personnel.
    • Provides oversight and leadership of process validation status and revalidation activities.
  • Supplier Quality Management:
    • 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.
  • Documentation and Compliance:
    • Prepare and review technical documentation, including protocols, validation plans, work instructions, and Standard Operating Procedures (SOPs).
    • 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.
  • Training and Mentorship:
    • Provide quality training to staff on cleanroom operations, regulatory compliance, and quality standards.
    • Support cross-functional teams in addressing quality concerns and implementing best practices for continuous improvement.
Qualifications:
  • 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.

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