Biomedical Engineer

Position: Quality Engineer II, Req#: CRNGJP00027225

Location: Woodland, CA, 95776 (100% onsite)

Duration: 12+ Months Contract

Hours of work/work schedule/flextime: Standard business hours, Monday – Friday

Travel Requirements: Less than 10%

Job Description:

Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for the site. Responsible for new product setup, quality project management, and regulatory compliance of serum products. Ensure compliance with in-house and/or external specifications and standards such as cGMPs, 21 CFR 820, ISO 13485, and Quality System Procedures.

Education and Experience:

• 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 of experience in Quality or Regulatory, preferably in a medical device, pharmaceutical or biotechnology environment/industry.
• 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 the 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

Roles and Responsibilities:

• Ensure compliance with 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
• Maintenance of BSE Serum Certificates of Suitability filing with EDQM
• Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.
• Serve as a resource for customers’ 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 customer quality audits, supplier quality audits and regulatory inspections
• Performs investigations and analysis activities to support the 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, processes, and quality systems.
• Training on quality systems and applicable regulations as identified by the supervisor and required by the position.
• Tracking/trending aspects of the QMS.
• Other job duties as required