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Quality Assurance Engineer II

2 months ago

Woodland, California, United States Mindlance Full time

Position Overview:
As a Quality Assurance Engineer II, you will play a crucial role in developing and maintaining the Quality Management System (QMS) and Regulatory Affairs (RA) initiatives that align with our quality objectives and performance metrics. You will be responsible for overseeing the setup of new products, managing quality projects, and ensuring regulatory adherence for serum products.

Key Responsibilities:
- Ensure adherence to evolving regulations impacting products and processes, including Quality System Regulations (QSR) and global import/export laws.
- Oversee the setup of new products and manage associated projects.
- Assist in conducting Supplier audits as necessary.
- Maintain the filing of BSE Serum Certificates of Suitability with the European Directorate for the Quality of Medicines (EDQM).
- Collaborate with the USDA on compliance activities, including regulatory approvals and import/export compliance.
- Serve as a point of contact for customer regulatory and technical inquiries.
- Maintain and enhance the ISO 13485-based quality system.
- Implement and manage Corrective and Preventive Actions (CAPA) and resolve quality issues.
- Coordinate Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition.
- Review and revise procedures, specifications, and forms to uphold and enhance the QMS.
- Act as the Quality Help Desk and manage customer complaints, including handling Questionnaires, Certificates, and Customer Surveys.
- Conduct Internal Audits to support compliance with internal requirements and regulatory standards.
- Represent the organization during customer quality audits, supplier quality audits, and regulatory inspections.
- Perform investigations and analyses to support the resolution of quality-related issues.
- Collaborate with cross-functional teams to facilitate the implementation of quality systems.
- Create new product master files that meet customer and quality system requirements.
- Uphold quality standards by adhering to company and departmental policies and procedures, including:
- Product performance and quality verification.
- Identifying, documenting, and investigating issues related to products, processes, and quality systems.
- Evaluating processes for improvements and standardization.
- Initiating 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.
- Perform other duties as assigned.

Travel Requirements:
Minimal travel, less than 10%.

Work Schedule:
Standard business hours, Monday to Friday.

Education Requirements:
A minimum of a Bachelor's degree in Science, Engineering, Bioengineering, or a related field is required, with a preference for degrees in Chemistry or Biology.

Experience and Skills:
- At least 3 years of experience in Quality or Regulatory roles, preferably within the medical device, pharmaceutical, or biotechnology sectors.
- In-depth knowledge and practical application of Quality Systems Regulations (21 CFR 820) and ISO 13485.
- Proficiency in developing, updating, and training on Standard Operating Procedures (SOPs).
- Familiarity with ISO standards and Quality Management Systems (QMS).
- Strong problem-solving skills for conducting investigations and driving root cause analysis.
- Experience in performing internal and external audits.
- Ability to monitor various aspects of the QMS, including Change Control, CAPA, Complaints, and Nonconforming Materials and Products.
- Knowledge of Continuous Improvement methodologies, Lean, or Six Sigma.

Desired Qualifications:
- Experience with SAP, EtQ, and/or PeopleSoft.
- Proficiency in statistical analysis.
- Project management experience.
- Knowledge of animal by-product import/export regulations.
- Familiarity with animal health, virology, immunology, or epidemiology.

Soft Skills:
- Exceptional organizational skills with the ability to manage multiple tasks.
- Strong interpersonal and communication abilities.
- Excellent time management skills and attention to detail.
- Capability to influence and collaborate effectively within a team environment.
- Ability to work independently with minimal supervision.

EEO Statement:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment based on minority status, gender, disability, religion, sexual orientation, age, or veteran status.