Quality Engineer II- Validation

The Quality Engineer II (QE II) will be an integral member of the BiVACOR quality team in supporting the quality related activities associated with the manufacture, test and distribution of the Total Artificial Heart (TAH) system. The QE II will also work with BiVACOR senior management to implement and supports maintenance of quality management system in accordance with ISO 13485 and 21 CFR 820, 803, and 806.

Job Summary:

This position is responsible for ensuring compliance with regulatory requirements (FDA, ISO, GMP) through the development, execution, and maintenance of validation protocols. This position focuses on Equipment Qualification (IQ/OQ/PQ), Process Validation and Test Method Validation to ensure product quality, reliability, and regulatory compliance. The ideal candidate will have strong technical expertise in medical devices, leadership skills, and the ability to drive continuous improvement in validation processes.

Key Responsibilities:

• Validation Leadership:
• Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and laboratory equipment.
• Develop and manage Process Validation (PV) strategies, including PPQ (Process Performance Qualification) and ongoing monitoring.
• Conduct Test Method Validation (TMV) to ensure accuracy, precision, and reproducibility of analytical methods.
• Regulatory Compliance:
• Ensure compliance with FDA, ISO 13485, GMP, EU MDR, and other regulatory standards.
• Author and review validation documentation (protocols, reports, SOPs) to meet regulatory expectations.
• Support internal/external audits and regulatory inspections (FDA, Notified Bodies).
• Risk Management & Continuous Improvement:
• Apply risk-based validation approaches to prioritize validation activities.
• Identify and implement process improvements to enhance efficiency and compliance.
• Lead investigations into deviations, non-conformances, and CAPA.
• Cross-Functional Collaboration:
• Work closely with Manufacturing and Engineering to ensure validation requirements are met.
• Train and mentor junior engineers on validation best practices.

Required Skills & Qualifications:

• Education: Bachelor’s degree in Engineering.
• Experience: 4+ years in Quality/Validation Engineering within medical devices, pharmaceuticals, or biotechnology.
• Technical Expertise:
• Strong knowledge of IQ/OQ/PQ, Process Validation, and TMV.
• Familiarity with FDA 21 CFR Part 11, Part 820, ISO 13485, and GMP.
• Experience with statistical tools (Minitab, JMP) and validation software.
• Soft Skills:
• Excellent problem-solving, project management, and communication skills.
• Ability to lead cross-functional teams and drive validation projects to completion.

Preferred Qualifications:

• ASQ Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE).

· Software Validation experience

• Experience with automated manufacturing systems, LIMS, or ERP systems.
• Knowledge of Six Sigma/Lean Manufacturing methodologies.

Job Type: Full-time

Pay: $91,900.00 - $99,600.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Work Location: In person