Quality Assurance Engineer

2 weeks ago

Woodland, California, United States Compunnel Inc. Full time

Position Title: Quality Assurance Engineer

Work Schedule: Standard business hours, Monday – Friday

Contract Duration: 12 months with potential for extension

Location: Woodland, CA

Educational Requirements: A minimum of a Bachelor's degree in a relevant field such as Science, Engineering, Bioengineering, or similar disciplines. Preference for candidates with degrees in Chemistry or Biology.

Role Overview:

  • Facilitate and enhance all Quality Management System (QMS) and Regulatory Affairs (RA) initiatives to support quality objectives and metrics.
  • Oversee the setup of new products, manage quality projects, and ensure compliance with regulations for serum products.
  • Guarantee adherence to internal and external specifications and standards, including cGMPs, 21 CFR 820, ISO 13485, and Quality System Procedures.

Key Responsibilities:

  • Ensure compliance with evolving regulations impacting products and processes.
  • Manage new product setups and related project oversight.
  • Assist with supplier evaluations as necessary.
  • Maintain documentation for BSE Serum Certificates of Suitability.
  • Collaborate with regulatory bodies on compliance activities, including approvals and safety testing.
  • Act as a resource for customer inquiries regarding regulatory and technical matters.
  • Maintain and enhance the ISO 13485-based quality system.
  • Implement and manage Corrective and Preventive Actions (CAPA) and resolve issues effectively.
  • Lead Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition processes.
  • Coordinate the review and updates of procedures, specifications, and forms to improve the QMS.
  • Serve as the point of contact for quality-related customer complaints and inquiries.
  • Conduct Internal Audits to support compliance with internal requirements and standards.
  • Represent the organization during customer quality audits and regulatory inspections.
  • Perform investigations and analyses to resolve quality-related issues.
  • Collaborate with teams to support the implementation of quality systems.
  • Create new product master files that meet customer and quality system standards.
  • Ensure quality standards are upheld by following company policies and procedures.
  • Identify, document, and investigate issues related to products, processes, and quality systems.
  • Evaluate processes for potential improvements and standardization.
  • Initiate actions to prevent non-conformance in products and processes.
  • Provide training on quality systems and relevant regulations as required.
  • Track and analyze aspects of the QMS.
  • Perform additional duties as assigned.

Essential Skills:

  • Comprehensive knowledge and practical experience with Quality Systems Regulations 21 CFR 820 and ISO 13485.
  • Ability to develop, revise, and train on Standard Operating Procedures (SOPs).
  • Familiarity with ISO standards and Quality Management Systems (QMS).
  • Proficient in problem-solving techniques for investigations and root cause analysis.
  • Experience conducting internal and external audits.
  • Ability to monitor various aspects of the QMS, including Change Control, CAPA, and Complaints.
  • Experience with Continuous Improvement methodologies, Lean, or Six Sigma.

Preferred Qualifications:

  • Experience with SAP, EtQ, or PeopleSoft.
  • Proficiency in statistical analysis.
  • Project management experience.
  • Knowledge of animal by-product import/export regulations.
  • Understanding of animal health, virology, immunology, or epidemiology.

Experience Requirements:

  • A minimum of 3 years of experience in Quality or Regulatory roles, ideally within the medical device, pharmaceutical, or biotechnology sectors.

Interpersonal Skills:

  • Ability to manage multiple tasks while maintaining organization.
  • Strong communication and interpersonal skills.
  • Excellent time management skills and attention to detail.
  • Capability to influence team members while collaborating across functions.
  • Ability to work independently with minimal oversight.

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