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Quality Assurance Engineer
2 months ago
What qualities are we seeking in our Quality Assurance Engineer?
Russell Tobin & Associates is collaborating with a global technology firm to find a Quality Assurance Engineer.
Your role will involve developing and supporting all Quality Management System (QMS) and Regulatory Affairs (RA) activities, aligning with the quality objectives and metrics for the organization. You will be accountable for the setup of new products, management of quality projects, and ensuring regulatory compliance for serum products. Your responsibilities will include ensuring adherence to internal and external specifications and standards such as cGMPs, 21 CFR 820, ISO 13485, and Quality System Procedures.
Key Responsibilities:
- Ensure compliance with evolving regulations impacting products and processes, including QSRs and global import/export regulations.
- Oversee new product setup and manage related projects.
- Assist with supplier audits as necessary.
- Maintain BSE Serum Certificates of Suitability filing.
- Collaborate with regulatory bodies on compliance activities, including approvals, import/export compliance, traceability, and safety testing.
- Act as a resource for customer regulatory and technical inquiries.
- Maintain an ISO 13485-based quality system.
- Implement and manage CAPA (Corrective and Preventive Actions) and problem resolution processes.
- Coordinate and lead Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition.
- Review and revise procedures, specifications, and forms to enhance the QMS.
- Serve as the point of contact for Quality Help Desk and customer complaints, including handling questionnaires and surveys.
- Conduct internal audits to support compliance with internal requirements, 21 CFR 820, and ISO 13485.
- Represent the organization in customer quality audits, supplier quality audits, and regulatory inspections.
- Perform investigations and analyses to resolve quality issues.
- Collaborate with teams to support the implementation of quality systems.
- Create new product master files that meet customer and quality system requirements.
- Ensure quality standards are upheld by following company and departmental policies and procedures.
- Identify, record, and investigate issues related to product, process, and quality systems.
- Evaluate processes for improvements and standardization.
- Initiate actions to prevent non-conformance in products, processes, and quality systems.
- Provide training on quality systems and applicable regulations as required.
- Track and trend aspects of the QMS.
Qualifications:
- Bachelor's degree in science, engineering, bioengineering, or a related field.
- In-depth knowledge and practical experience with Quality Systems Regulations 21 CFR 820 and ISO 13485.
- Ability to develop, update, and train on Standard Operating Procedures (SOPs).
- Familiarity with ISO standards and Quality Management Systems (QMS).
- Proficient in problem-solving techniques for investigations and root cause analysis.
- Experience conducting internal and external audits.
- Ability to monitor the QMS, including Change Control, CAPA, Complaints, and Nonconforming Materials and Products.
- Experience with Continuous Improvement methodologies, Lean, or Six Sigma.
Preferred Qualifications:
- Bachelor's degree in Chemistry or Biology.
- At least 3 years of experience in Quality or Regulatory roles, preferably within the medical device, pharmaceutical, or biotechnology sectors.
Benefits Offered by Russell Tobin:
Russell Tobin provides eligible employees with comprehensive healthcare coverage, including medical, dental, and vision plans, as well as supplemental coverage options, a 401(k) retirement savings plan, life and disability insurance, and an employee assistance program. Additional benefits include identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with select vendors.
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