Quality Engineer II

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• 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.
  
  

Job Description

• 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.
  
  

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.
  
  

Requirements:

• 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.
• 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
• 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.

Seniority level

• Seniority level Associate

Employment type

• Employment type Contract

Job function

• Job function Quality Assurance
• Industries Pharmaceutical Manufacturing

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