Meddev Principal Qa Engineer Process Validation

About the Role

We are seeking an experienced Principal Quality Assurance Engineer to join the Process Validation Group supporting reagent manufacturing operations in Miami, Florida. This role is ideal for a quality engineering professional with strong expertise in process validation, qualification activities, and quality management systems within the medical device or life sciences industry.

As a key member of the Process Validation team, you will work closely with senior QA leadership and take ownership of Process Validation Reagents within reagent manufacturing. You will be responsible for developing, executing, reviewing, and maintaining validation deliverables, including IQ/OQ, PQ, TMV, and other qualification activities.

The ideal candidate has a strong understanding of 21 CFR Part 820, ISO 13485, and validation methodologies, along with practical experience in spreadsheet validation, quality systems, and regulated manufacturing processes.

• Develop, write, review, and execute Installation and Operational Qualification (IQ/OQ) protocols for manufacturing equipment, processes, and systems.

• Perform spreadsheet validation activities to ensure accuracy, reliability, and compliance of automated and electronic tools.

• Plan, execute, and complete Performance Qualification (PQ), Test Method Validation (TMV), and AQ validation activities.

• Support process validation activities for reagent manufacturing operations.

• Develop and maintain validation protocols, procedures, reports, and supporting documentation.

• Monitor and audit Quality Management Systems (QMS) to ensure compliance with applicable regulatory requirements and industry standards.

• Evaluate manufacturing processes, equipment, and automated systems to identify validation requirements and compliance gaps.

• Collaborate with Process Validation, Quality Assurance, Engineering, and Manufacturing teams to resolve validation-related issues.

• Ensure validation activities are performed in accordance with established procedures, quality standards, and regulatory expectations.

• Support systems automation, process improvements, and the development of standardized validation procedures.

• Review validation results, identify deviations, and support appropriate investigation and corrective actions.

• Maintain accurate validation records and ensure documentation is complete and audit-ready.

• Provide technical guidance on validation methodologies and quality compliance requirements.

• Bachelor's degree in Engineering, preferably Mechanical, Electrical, Chemical, Bioengineering, or a related engineering discipline.

• 5+ years of experience in the medical device industry, preferably within Quality Assurance, Process Validation, or regulated manufacturing.

• Hands-on experience developing, writing, reviewing, and executing IQ/OQ validation protocols.

• Experience with process validation and qualification activities within regulated manufacturing environments.

• Familiarity with 21 CFR Part 820 and ISO 13485 quality and regulatory requirements.

• Proficiency in Microsoft Excel, including working with spreadsheets and validation documentation.

• Good working knowledge of computer systems, programming concepts, and automated processes.

• Strong technical writing, analytical, and problem-solving skills.

• Ability to work collaboratively with cross-functional engineering, quality, and manufacturing teams.

• Strong understanding of quality documentation, compliance requirements, and validation practices.

• Experience executing PQ (Performance Qualification), TMV (Test Method Validation), AQ, and NPSV validation activities.

• Exposure to GAMP 5 guidelines or similar computerized system validation regulations and industry standards.

• Previous experience supporting reagent manufacturing or laboratory-related manufacturing operations.

• Familiarity with spreadsheet validation, automated systems, and computerized manufacturing processes.

• ASQ Certified Quality Engineer (CQE) certification.

• Experience supporting regulatory audits, quality system assessments, and validation documentation reviews.

• Strong understanding of risk-based validation approaches and continuous improvement methodologies.