Quality Engineer

Overview

The Quality Engineer will play a critical role in ensuring the quality and compliance of our medical devices throughout the product lifecycle. This position involves implementing and maintaining quality management systems, managing non-conformances, and driving continuous improvement initiatives. The ideal candidate will have a strong understanding of medical device regulations and a passion for ensuring product safety and efficacy. This is a full-time, on-site position.

• Product Quality
  • Support product development and design verification/validation activities.
  • Develop and implement quality control plans for manufacturing processes.
  • Analyze quality data and identify trends to drive continuous improvement.
• Validation and Qualification
  • Support test method, process, cleanroom, and equipment validations (IQ/OQ/PQ).
  • Create and maintain validation documentation.
  • Establish and monitor triggers for re-validation and periodic review of validated processes and equipment to ensure they remain in a qualified state.
• Quality Management System (QMS)
  • Support development, implementation, and maintenance of the company's QMS to ensure compliance with ISO 13485, 21 CFR Part 820, and other applicable regulations.
  • Ensure QMS documentation is accurate, up-to-date, and effectively implemented.
• Auditing and Compliance
  • Assist the QA Department in conducting internal and external audits to assess compliance with regulatory requirements and company procedures.
  • Support regulatory submissions and inspections.
• Non-Conformance and CAPA
  • Assist the CAPA Process Owner investigating and resolving non-conformances.
  • Ensure thorough root cause analysis and effective corrective actions.
• Risk Management
  • Conduct risk assessments and develop risk management plans in accordance with ISO 14971.
  • Ensure risk management activities are integrated into product development and manufacturing processes.
• Safety, Organization, and Productivity
  • Know, understand and adhere to all safety standards, i.e., emergency preparedness, chemical, infectious agents and radioactive hazards.
  • Participate in the introduction and evaluation of new procedures, supplies and equipment.
  • Ensure proper training of colleagues.
  • Use resources (equipment, disposables, time) in a responsible, cost‑effective manner.

• Education: Bachelor’s degree in engineering, science, or a related field.
• Experience: Minimum 3 years of experience in quality engineering within the medical device industry; strong knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and other applicable medical device regulations; experience with auditing, CAPA, risk management, and validation; proficient in using quality management software and tools; ASQ Certified Quality Engineer (CQE) is highly desirable; experience with statistical process control (SPC);
  
  experience with design control; working knowledge of MRP or MES systems, preferably in Microsoft Dynamics 365.
• Skills: Strong analytical and problem‑solving skills and effective application of data and statistical analysis techniques; effective communication and presentation skills; people‑focused leadership, coaching and development; willingness to mentor others; demonstrated ethics and integrity, resourcefulness, and flexibility; results focus and decision‑making capability; ability to work independently and manage projects, tasks and time efficiently; proven experience in validation and qualification; proficiency in ERP, especially Microsoft Dynamics 365;
  
  technical writing.

• Ability to travel domestic and international.

• Mobility & Posture: May require occasional sitting, standing, walking, climbing, reaching, bending, or stooping.
• Lifting/Carrying: May require lifting and carrying items 50 pounds or more, depending on the role.
• Manual Dexterity: Frequent use of hands and fingers for typing, writing, grasping, and operating office or job‑specific equipment.
• Driving: Some roles may require the ability to operate a motor vehicle for extended periods and maintain a valid driver’s license.

• Listing on the SIX Swiss Exchange under the symbol KURN since 2016.
• A commercial & research footprint that spans >20 markets.
• Dozens of clinical and scientific expert advisers.
• >25 orthobiologics-related patents.
• >400 patients evaluated in Level I, randomized controlled clinical trials.
• >20 well‑controlled Level I‑IV clinical trials initiated, including 6 that are complete.
• Published Level I evidence published in Spine.

• Seniority level:
  Mid‑Senior level.
• Employment type:
  
  Full‑time.
• Industries:
  Construction, Software Development, and IT Services and IT Consulting.