Senior Quality Engineer

The Senior Supplier Quality Engineer will be responsible for quality engineering activities that address product/process changes, product/process quality issues, and compliance issues. This person will partner with operations for process improvement and continuous improvement initiatives and perform process audits of the operations areas. This person may be involved in the development of new products and as such would support design control activities.

What You'll Work On

• Drive continuous process improvement by partnering with Operations to conduct process audits, identify opportunities, and implement sustainable enhancements that improve quality, efficiency, and compliance.
• Lead the development, implementation, and monitoring of process control systems and Critical-to-Quality (CTQ) measures to ensure products consistently meet internal, customer, and regulatory requirements.
• Provide Quality Assurance support for IVD medical device development and lifecycle management, ensuring compliance with design controls, risk management, quality planning, verification, validation, and change control processes.
• Lead risk management activities, including risk assessments, FMEA, and failure mode analysis, to identify potential issues and implement effective mitigation strategies.
• Investigate, resolve, and prevent product and process nonconformances through structured problem-solving, root cause analysis, CAPA, and quality improvement methodologies.
• Design, execute, and document process optimization studies, experiments, protocols, and reports to support continuous improvement and product quality.
• Collaborate cross-functionally with R&D, Manufacturing, Quality Control, Applications Support, and Design Engineering teams to proactively address quality challenges and drive effective solutions.
• Champion Lean Manufacturing, Six Sigma, and other operational excellence initiatives to improve product performance, manufacturing processes, and overall business effectiveness.
• Manage multiple projects and priorities while providing leadership, coaching, and mentorship to support team development and successful project execution.
• Ensure compliance with Quality Management Systems (QMS), ISO, FDA, EMS, and company policies by supporting audits, regulatory requirements, documentation, validation activities, and continuous quality system improvement.

Required Qualifications

• Bachelors in fields of science such as Chemistry, Microbiology, Biology, Biochemistry, or Engineering.
• Minimum 5 years experience in a quality role within the biotechnology industry with 3-5 years of progressive responsible positions.

Preferred Qualifications

• Direct work experience in IVD or medical device/biotech or regulated manufacturing environment.
• ASQ CQE or other certifications preferred.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Experience including new product development, design transfer, validation, QMS, and Supplier Audit experience is desired. Experience with reagent, ELISA, HEIA manufacturing desired.
• Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor desired.
• Demonstrated supervisory experience preferred.
• Knowledge of IVDR in EU, FDA QSRs, ISO 13485:2016, ISO 14971:2012 standards and HACCP, GMP, GLP and GDP requirements.