Quality Engineer

#Change Makers Ready to make an impact?

We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.

We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others.

We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful “can-do” attitude.

The Quality Engineer strengthens product and process robustness across manufacturing by applying structured quality engineering principles, statistical analysis, and risk-based decision-making in a regulated medical device environment (ISO 13485, FDA QSMR, GMP). This role partners closely with Manufacturing, QC, Engineering, Supplier Quality, and Operations to ensure product conformity, improve process capability, reduce scrap, and reinforce preventive controls. The Quality Engineer supports technology transfers, validation activities, internal audits, and supplier quality oversight while driving data-based continuous improvement.

The position provides technical leadership in quality engineering disciplines and ensures compliance, sustainability, and operational excellence across implant and prosthetic value streams.

• Develop and maintain robust quality plans including control strategies, sampling methods, inspection criteria, and metrology approaches.
• Conduct process capability studies, statistical analysis, PFMEA, risk assessments, and measurement system evaluations (MSA/GR&R) to reduce variation and improve process stability.
• Analyze scrap trends, NCR data, and yield performance to identify systemic improvement opportunities.
• Recommend and implement engineering solutions in compliance with ISO 13485, FDA QSMR, and internal quality system requirements.
• Develop and revise SOPs, work instructions, ECOs, control plans, and related documentation to ensure clarity and compliance.

• Support technology transfers and product introductions by defining quality requirements and inspection strategies.
• Execute and support IQ/OQ/PQ activities in alignment with the Validation Master Plan.
• Prepare and review validation documentation including protocols, reports, PFMEAs, and risk assessments.
• Conduct revalidation assessments to maintain long‑term process compliance and risk mitigation.

• Provide structured troubleshooting support to machining, finishing, cleaning, packaging, and inspection processes.
• Lead or facilitate root cause investigations using structured methodologies (5 Why, Fishbone, 8D, DMAIC).
• Ensure corrective and preventive actions are timely, effective, and verified for sustainability.
• Collaborate with Manufacturing Engineering and Production teams to improve process flow and defect prevention.

• Plan, conduct, and document internal audits to ensure regulatory and corporate audit readiness.
• Serve as subject matter expert in manufacturing process audits, SPC, validation, and document control.
• Support audit responses, corrective action plans, and effectiveness verification within defined timelines.
• Ensure inspection plans, sampling strategies, and test methods remain aligned with regulatory expectations.

• Partner with Supplier Quality to qualify and monitor suppliers of machined components, coatings, raw materials, and surface treatments.
• Review supplier documentation including PPAPs, FAI reports, material certifications, and capability studies.
• Support supplier audits and corrective action processes (SCARs) as required.

• Apply Lean and Six Sigma tools to reduce variation, strengthen process control, and improve reliability.
• Support…