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Integrated Resources

Quality Engineer II

Integrated Resources, Woodland

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Job Title: Quality Engineer II
Location: Woodland, CA 95776
Duration: 12 Months+ (Possibility of Extension)
Schedule: Standard business hours, 8 am - 5 pm, Monday - Friday
Travel Requirements: Less than 10% (Possibility)
Pay Range: $50 - $53/hr. on w2
Job Description:
Scope of Position:
  • Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site.
  • Responsible for new product setup, quality project management, and regulatory compliance of serum products.
  • Ensure compliance to in-house and/or external specifications and standards such as cGMPs, 21 CFR 820, ISO 13485, and Quality System Procedures.

Day to Day Responsibilities:
  • Ensure compliance to new and changing regulations affecting products and processes including, but not limited to, QSR's, global import/export regulations, etc.
  • New product setup and management of related projects
  • Assist with Supplier audits, as needed
  • Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.
  • Serve as a resource for customer's regulatory and technical inquiries
  • Ongoing maintenance of ISO 13485 based quality system
  • Implement and handle CAPA (Corrective and Preventive Actions) and problem resolution.
  • Coordinates and leads Quality Documentation, Nonconformance Reports, Inspection
  • Activities and Product Disposition.
  • Coordinates the review and revision of procedures, specifications, and forms to maintain and improve the QMS.
  • Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates and Customer Surveys, etc.
  • Perform Internal Audits in support of internal requirements, 21 CFR 820 and ISO 13485 compliance.
  • Assists in representing in customer quality audits, supplier quality audits and regulatory inspections
  • Performs investigations and analysis activities to support resolution of quality issues.
  • Collaborates with organizational teams to support quality system implementation.
  • Creation of new product master files satisfying customer and quality system requirements
  • Ensures quality standards by following company & departmental policies & procedures including, but not limited to:
  • Product performance & quality verification.
  • Identifying, recording, and investigating problems related to product, process & quality systems.
  • Evaluating processes for improvements and standardization.
  • Initiating action to prevent non-conformance in products, process, and quality systems.
  • Training on quality systems and applicable regulations as identified by supervisor and required by position.
  • Tracking/trending aspects of the QMS.
  • Other job duties as required

Required Education:
  • Minimum of Bachelor's degree in Science, Engineering, Bioengineering or related field. Prefer Chemistry or Biology degree programs.
  • Preferred Education, Years and Area of Experience:
  • Minimum 3 years' experience in Quality or Regulatory, preferably in a medical device, pharmaceutical or biotechnology environment/industry.

Required Skills:
  • Thorough knowledge and practical application of Quality Systems Regulations 21 CFR 820 and ISO 13485
  • Ability to develop, update and train on SOPs.
  • Working knowledge of ISO standards and Quality Management Systems (QMS).
  • Problem solving techniques to perform investigations and drive root cause analysis.
  • Related work experience performing internal/external audits.
  • Ability to monitor the QMS such as: Change Control, CAPA, Complaints, Nonconforming Materials and Products.
  • Experience with Continuous Improvement, Lean or Six Sigma.

Desired Experience / Qualifications / Skills:
  • SAP, ETQ and/or PeopleSoft experience.
  • Experience with statistical analysis.
  • Project management experience.
  • Animal by-product import/export regulations
  • Animal health and/or virology, immunology, epidemiology knowledge

Soft Skills:
  • Ability to multi-task with ability to be organized.
  • Strong interpersonal and communication skills.
  • Strong time management skills and attention to detail.
  • Ability to influence others in a team environment while collaborating with peers and functional areas.
  • Ability to work independently with minimal supervision