Quality Engineer

Summary Statement

For more than a century Ottobock has pursued the mission of helping people living with limb loss or mobility challenges regain or maintain their freedom of movement. We do this through the development of leading prosthetic, orthotic and wheelchair innovation and an unwavering commitment to delivering superior patient care experiences. As a growing healthcare company, we continue to invest in both our people and new service offerings. With more than 10,000 employees worldwide and 1,100 across North America, we are dedicated to advancing the O&P industry and improving the lives of the people served by it.

We are looking for a Quality Engineer to join our team onsite in Salt Lake City, UT!

The Quality Engineer will be responsible for ensuring the effectiveness of quality management systems (QMS) in the medical device manufacturing process, ensuring compliance with regulatory requirements and industry standards (such as FDA, EU MDR & ISO 13485) and customer requirements. This role involves identifying quality issues, driving corrective actions, supporting cross-functional teams, and fostering continuous improvements in quality systems, manufacturing processes, and product performance.

Duties & Responsibilities

• Lead and manage the non-conformance review process, ensuring proper disposition of parts and issue resolution.

• Oversee non-conformance reports (NCRs) to minimize recurring issues and improve quality standards.

• Track key performance metrics, analyze trends, and provide insights for continuous improvement.

• Ensure quality control during production, collaborating with inspectors to maintain compliance.

• Integrate quality standards into new product design and manufacturing processes.

• Oversee initial product inspections to ensure readiness for full-scale production.

• Lead corrective and preventive actions (CAPA) to address production issues.

• Maintain accurate, compliant quality documentation and records per company standards.

Qualifications

• Bachelor’s degree in engineering (Mechanical, Electrical, Manufacturing, or related field) or equivalent experience.

• 3+ years of experience in a quality engineering role within a regulated industry (medical device, pharmaceutical, etc.).

• Experience with quality tools such as root cause analysis, CAPA, and statistical process control (SPC).

• Strong problem-solving and analytical skills, with the ability to interpret complex technical data.

• Familiarity with quality control methods, statistical analysis, and process improvement techniques.

• Knowledge of FDA & EU regulations, ISO 13485, and quality management systems.

• Ability to communicate effectively with cross-functional teams and manage multiple priorities in a fast-paced environment.

• Proficiency in quality management software and tools (e.g., MS Word, Power-BI, Excel, PowerPoint, SAP, Arena, etc.).

Benefits

• Medical

• Vision

• Dental

• Health savings accounts with employer contribution

• Flexible spending account options

• Company-paid life insurance policy

• Paid time off

• Company holidays

• Floating holidays

• 100% company-paid short & long-term disability

• 401k match up to 3.5%