Quality Engineer II
Quality Engineer II
Posted on :
14-08-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
14-08-2025
Job Description
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.
- Ensure compliance to new and changing regulations affecting products and processes including but not limited to QSRs 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 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 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.
- Minimum of bachelors 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.
Employment Type
Full-time
Key Skills
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