Quality Engineer II

• Apply Validation Principles and Design Control processes in accordance with applicable regulatory and industry requirements (including ISO standards, ASME BPE, CE, BPOG, REACH, and others), ensuring product and process quality throughout development and commercialization.

• Support the New Product Introduction (NPI) team through the deployment of Quality Engineering tools that enable the effective development, transfer, and lifecycle management of products and processes. Partner closely with cross-functional teams to verify development deliverables and maintain Design History Files that support successful product release.

• Provide guidance and support in Design Controls and Risk Management activities for new product development and design change projects. Collaborate with Engineering, Manufacturing, and Product Development teams to proactively identify risks and drive quality-focused decision making.

• Support the completion of Risk Management activities (FMEA), Design Verification, and Process Verification efforts to ensure products and processes consistently meet quality and performance expectations.

• Assist in the development, validation, and continuous improvement of test methods that effectively evaluate product and process performance.

• Review Equipment IQ/OQ/PQ documentation in support of commercial manufacturing operations.

• Demonstrate strong organizational skills and the ability to effectively manage multiple priorities while maintaining attention to detail and a focus on execution.

• Bring a self-directed approach, exercising sound judgment, accountability, and problem-solving skills to support quality objectives and business needs.

• Participate in customer complaint investigations, partnering with stakeholders to identify root causes and implement sustainable corrective actions.

• Execute change controls and facilitate Change Control Review Board activities, ensuring effective communication, alignment, and timely decision making across impacted teams.

• Review and approve nonconformances, deviations, failure investigations, and corrective action plans, helping ensure robust solutions are implemented and sustained.

• Utilize Lean and Six Sigma methodologies to identify opportunities, improve processes, reduce risk, and support a culture of continuous improvement.

Qualifications

• Bachelor's degree in Biological Science, Engineering, Physical Science, or a related discipline.

• Demonstrated experience in New Product Development Quality Engineering.

• Experience supporting biotech hardware, consumable products, and associated manufacturing processes.

• Working knowledge of cell culture, filtration, and chromatography operations within a bioprocessing environment.

• ASQ Certified Quality Engineer (CQE), CRE, or equivalent certification preferred.

• Minimum of 5 years of Quality Engineering experience within an ISO 9001 Quality Management System or equivalent regulated environment.

• Internal auditing experience.

• Strong communication and relationship-building skills, with the ability to effectively collaborate across technical and operational functions.

• Ability to influence outcomes, navigate complex challenges, and contribute to informed, risk-based decision making.

• Proven ability to drive results, manage competing priorities, and support continuous improvement initiatives in a fast-paced environment.