Quality Engineer

POSITION SUMMARY

The Quality Engineer plays a vital role in ensuring the organization’s ongoing compliance with established quality assurance standards for manufacturing and production. This position supports both initial compliance efforts and continuous monitoring, testing, and improvement of quality processes.

Key responsibilities include analyzing trends in internal controls, conducting risk assessments, and proactively identifying and evaluating potential deficiencies. The Quality Engineer collaborates closely with cross‑functional teams to develop and implement effective solutions, ensuring robust corrective and preventive actions.

As a technical resource, the Quality Engineer participates in problem investigation, guides root cause analysis, and supports the development of sustainable corrective actions. This role is responsible for investigating assigned CAPAs, complaints, and NCRs to root cause, driving timely and effective resolutions. Additionally, the Quality Engineer contributes to product improvement and manufacturing investigation, supporting a culture of continuous improvement and operational excellence.

• Develop and Document Test Methodologies: Design and document validation and verification for equipment, methods, material, and instrumentation. Determine appropriate sampling plans and measurements for reagent formulation production, monitoring performance and identifying potential emerging issues.
• Proactive Monitoring and Trending: Conduct ongoing monitoring and trending of quality and manufacturing data to proactively identify and address emerging issues. Promptly notify management of potential risks and contribute to continuous improvement initiatives.

Engage in clear, professional communication with production teams to identify root causes and drive process improvements.

• ERP Transactions for Non‑Conformances: Process ERP transactions to segregate and disposition non‑conforming product, ensuring proper documentation and traceability.
• Procedure and Process Improvement: Assist with developing, reviewing and improving procedures and processes related to product quality.
• Audit support: Participate in internal and external audits, supporting audit readiness and compliance.
• Additional Quality Duties: Perform other responsibilities within the Quality Department as assigned, contributing to the overall success of the team.
• Non‑Conformance Reporting (NCR): Monitor NCRs for trends, proactively address quality issues, and escalate to CAPA as necessary.
• Material Review Board (MRB) Participation: Support and participate in MRB for product review, control and disposition.
• Incoming QC Specifications: Develop and/or improve incoming QC specifications (inspection criteria and sampling plans). Collaborate with QC Technicians to maintain efficient material flow for production needs.
• Validation Program Participation: Actively participate in the Validation Program, including review and approval of validation protocols and reports. Ensure robust equipment qualifications, product and process validations. Support validation teams to achieve project milestones and document process risk analyses. Serve as in‑house expert for Process Validation, equipment qualification, and process risk analysis (pFMEA).
• Product Development Support: Represent QA in product development activities, including design reviews and risk management. Review and approve Design History File (DHF) documents, ensuring compliance to design control requirements.

• Bachelor’s degree required, preferralby in science, engineering, or veterinary fields. Advanced degrees (MS) in Science or Engineering are a plus.
• A minimum of three years’ experience in an FDA‑regulated environment within the medical device or in‑vitro diagnostics industry preferred.
• Demonstrated knowledge or hands‑on experience in ISO
  9001, ISO
  13485, ISO
  14971 standards.
• ASQ CQE / CQA certification preferred.
• Lyophilization experience is a plus.

• Strong attention to details and ability to understand and follow complex procedures.
• Strong technical skills including statistical techniques.
• Proficient in basic computer…