Quality Engineer II - Integrated Resources, Inc
Woodland, CA 95776
About the Job
Job Title: Quality Engineer II
Location: Woodland, CA
Duration: 12+ Months With Possible Extension
Work Schedule: M-F 8hours/Day
Job Description:
Product of Position:
Day to Day Responsibilities:
o Identifying, recording, and investigating problems related to product, process &
quality systems.
o Evaluating processes for improvements and standardization.
o 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
Travel Requirements: Less than 10%
Hours of work/work schedule/flextime: Standard business hours, Monday – Friday
Required Education:
Required Skills:
Desired Experience / Qualifications / Skills:
Location: Woodland, CA
Duration: 12+ Months With Possible Extension
Work Schedule: M-F 8hours/Day
Job Description:
Product 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
- 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 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
o Identifying, recording, and investigating problems related to product, process &
quality systems.
o Evaluating processes for improvements and standardization.
o 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
Travel Requirements: Less than 10%
Hours of work/work schedule/flextime: Standard business hours, Monday – Friday
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
Source : Integrated Resources, Inc
