Manufacturing Quality Engineer II – Validation

Manufacturing Quality Engineer II – Validation

Dana Summers T13:32:51-08:00

OVERVIEW

This position is responsible for ensuring compliance with regulatory requirements (FDA, ISO, GMP) by developing, executing, and maintaining 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.

Continuous Improvement

• Support Lean and Six Sigma methodologies to enhance efficiency.
• Drive initiatives to reduce defects, improve yield, and optimize processes.
• Support strategies for cost‑effective quality improvements.
• Support quality improvement models, corrective and preventive action, and overcoming barriers to quality improvement.
• Participation in external audits – develop a response to queries during and following the audit.
• Initiate action to prevent the occurrence of non‑conformities relating to the product, process, and quality system, and follow through the non‑conformance and failure investigation process affecting Quality, and report verbally and in writing to the executive team regarding the progress and results of projects.

Cross‑Functional Collaboration

• Work closely with R&D, Regulatory Affairs, and Manufacturing teams.
• Provide technical guidance on quality‑related issues.
• Train and mentor junior quality engineers.
• With the assistance of Quality and Regulatory personnel, prepare and maintain documentation suitable for regulatory submissions for IDE human clinical studies.

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.

SALARY: $91,900 – $99,600 annually, based on experience

To apply, please send a cover letter and resume to

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