Lead Quality Assurance Engineer

2 weeks ago

Woodland, California, United States Compunnel Inc. Full time

Position Title: Senior Quality Assurance Engineer

Compensation: 45-50 USD/HR on W2

Contract Duration: 12 Months (extension likely)

Location: Remote

Overview:

As a Senior Quality Assurance Engineer, you will play a pivotal role in ensuring adherence to evolving regulations that impact our products and processes. Your expertise will be essential in maintaining the highest quality standards across our operations.

Key Responsibilities:

  • Oversee compliance with new and existing regulations affecting product quality and operational processes.
  • Manage the setup of new products and lead associated projects.
  • Support supplier evaluations and audits as necessary.
  • Maintain regulatory documentation and certifications.
  • Collaborate with regulatory bodies on compliance initiatives, including approvals and safety assessments.
  • Act as a primary resource for regulatory and technical inquiries from clients.
  • Ensure ongoing compliance with ISO 13485 quality management systems.
  • Implement and manage Corrective and Preventive Actions (CAPA) and facilitate problem resolution.
  • Lead the documentation of quality processes, nonconformance reports, and inspection activities.
  • Review and update quality procedures and specifications to enhance the Quality Management System (QMS).
  • Serve as the point of contact for quality-related customer inquiries and complaints.
  • Conduct internal audits to ensure compliance with quality standards.
  • Assist in customer and supplier quality audits and regulatory inspections.
  • Perform investigations and analyses to resolve quality-related issues.
  • Collaborate with cross-functional teams to support the implementation of quality systems.
  • Create and maintain product master files that meet customer and quality requirements.
  • Ensure adherence to company policies and procedures regarding product quality and performance.
  • Identify and document quality-related issues and initiate corrective actions.
  • Evaluate processes for potential improvements and standardization.
  • Provide training on quality systems and relevant regulations as required.
  • Monitor and report on various aspects of the QMS.

Additional Responsibilities:

Travel Requirements: Minimal travel expected.

Work Schedule: Standard business hours, Monday to Friday.

Education Requirements:

A Bachelor's degree in Science, Engineering, Bioengineering, or a related field is required, with a preference for degrees in Chemistry or Biology.

Experience Requirements:

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

Essential Skills:

  • In-depth knowledge of Quality Systems Regulations (QSR) and ISO 13485.
  • Proficient in developing and training on Standard Operating Procedures (SOPs).
  • Familiarity with Quality Management Systems (QMS) and ISO standards.
  • Strong problem-solving skills for conducting investigations and root cause analysis.
  • Experience in performing internal and external audits.
  • Ability to manage various QMS components, including Change Control and CAPA.
  • Experience with Continuous Improvement methodologies, such as Lean or Six Sigma.

Preferred Qualifications:

  • Experience with SAP, EtQ, or PeopleSoft.
  • Knowledge of statistical analysis techniques.
  • Project management experience.
  • Understanding of animal by-product import/export regulations.

Soft Skills:

  • Strong organizational and multitasking abilities.
  • Excellent interpersonal and communication skills.
  • Effective time management and attention to detail.
  • Ability to influence and collaborate with team members across functions.
  • Capability to work independently with minimal supervision.

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