Staff Quality Assurance Engineer

ZipRecruiter; Miami (FL); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Engineer to enhance quality management systems and ensure compliance with regulations. This role involves leading projects, managing CAPA items, and collaborating across departments to maintain product safety and effectiveness. With a focus on data analysis and process improvement, you will play a crucial role in driving quality initiatives. The ideal candidate will bring extensive experience in the engineering or quality field, strong analytical skills, and a passion for ensuring high standards in a dynamic environment. Join a forward-thinking team and make a significant impact on product quality and safety.

Qualifications

• 6-8 years of experience in engineering or quality roles.
• Strong knowledge of FDA, AATB, and cGTP guidelines.

Responsibilities

• Lead tasks or projects to successful completion with minimal guidance.
• Manage CAPA system items and ensure compliance with standards.
• Analyze quality metrics trends and recommend improvements.

Skills

Analytical Skills

Problem-Solving Skills

Project Management

Communication Skills

Microsoft Office Proficiency

Education

Bachelor’s degree in Engineering

Proficiency in Microbiology

Job description

Job Description

Job Purpose

The Quality Assurance Engineer develops, applies, revises, and maintains quality metrics to support operations at Vivex Biologics, Inc. The role involves planning, developing, implementing, communicating, and maintaining Vivex’s quality management systems, policies, documentation, data, and customer requirements. The engineer collaborates across departments to ensure compliance, safety, reliability, and effectiveness of final products, and ensures the successful and timely completion of projects. A primary responsibility is maintaining CAPA system items, playing a key role in issue prevention and resolution by defining, monitoring, and approving necessary processes.

Duties and Responsibilities

1. Lead specific tasks or small projects to successful completion with minimal guidance.
2. Manage CAPA system items: non-conformances, deviations, corrective and preventive actions, supplier corrective actions, and complaints.
3. Collaborate with CAPA owners and cross-functional teams to ensure proper documentation in compliance with procedural and technical standards.
4. Conduct data analysis, make recommendations for tissue safety/quality, and manage the disposition of nonconforming products.
5. Provide quality guidance, solve technical problems, and contribute to project milestones with cross-functional teams.
6. Analyze quality metrics trends to recommend improvements and corrective actions.
7. Support investigations and root cause analyses, implementing effective corrective actions.
8. Assist with change control activities, reviewing and providing feedback to ensure compliance.
9. Identify manufacturing process risks and implement mitigation measures.
10. Report on key quality metrics during meetings.
11. Assist in developing, reviewing, and maintaining quality policies and SOPs.
12. Ensure compliance with all relevant regulations, policies, and procedures.
13. Support validation activities, including protocol development and execution.

Qualifications

• Bachelor’s degree in engineering or related technical field (e.g., Biology, Chemistry), with proficiency in microbiology.
• 6-8 years of experience in engineering or quality roles.
• Strong knowledge of FDA, AATB, and cGTP guidelines.
• Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry.
• Experience with Non-Conformance, Deviation, Complaint, and CAPA processes.
• Proficiency in Microsoft Office applications.
• Effective communication and presentation skills.
• Strong analytical and problem-solving skills.
• Project management skills.
• Ability to influence others and lead change.

Working Conditions

Office and laboratory environments, occasional clean room access, with exposure to human tissue and biohazards.

Physical Requirements

Prolonged sitting; occasional lifting up to 20 pounds.

Direct Reports

No direct reports; this is an individual contributor role.

Management may reassign duties as needed. Vivex Biologics, Inc. is an equal opportunity employer, prohibiting discrimination and harassment in all forms, including based on race, color, religion, sex, gender identity, sexual orientation, genetic information, or veteran status. The company complies with the ADA, supporting individuals with disabilities in performing essential job functions.