Quality Engineer II

The Quality Engineer is responsible for ensuring product and process quality throughout operations and New Product Introduction (NPI). This role works cross-functionally with suppliers, production, and design teams to resolve quality issues, support audits, and ensure compliance with internal procedures and customer requirements.

Responsibilities

• Communicate with suppliers to resolve quality issues, manage nonconformities, handle claims, and support supplier audits

• Support production quality problem-solving in cooperation with production and manufacturing engineers

• Interface with the design team to communicate and resolve quality issues arising during production

• Manage and support incoming inspection activities, including inspection criteria and issue resolution

• Plan, perform, and support internal audits to ensure compliance with quality systems and procedures

• Participate in the creation and review of User Requirement Specifications (URS), ensuring requirements are clearly defined and include appropriate quality criteria

• Perform gate checks in accordance with the NPI SOP to ensure deliverables meet quality requirements before progression to the next project phase

• Ensure document control and maintenance of Design History File (DHF) and Device Master Record (DMR)

• Participate in formal design reviews at each project stage to ensure quality deliverables are met

• Support FMEA activities in NPI projects to identify, reduce, and eliminate quality risks

• Review and sign off Verification & Validation documentation, Traceability Matrix, and Design Input files to confirm all URS requirements are fulfilled

Qualifications & Skills

• Bachelor’s degree in Engineering, Quality, or a related technical field

• Experience in quality engineering within manufacturing or regulated environments (e.g., medical devices, automotive, electronics), 5+ years of job‑related experience.

• Knowledge of quality tools such as FMEA, root cause analysis, and corrective/preventive actions

• Familiarity with audits, document control, and quality management systems

• Strong communication skills and ability to collaborate across functions and with external suppliers

• Detail-oriented, analytical, and proactive problem solver

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated hourly rate/salary range for this role, is $ €33,600 – €42,000. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.