Senior Quality Engineer - Combination Product

Company Description

medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from our dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 14 production sites worldwide, together with our highly motivated and experienced team of nearly 2’600 employees provide our customers with uncompromising quality, proximity, and agility. medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX). www.medmix.swiss

Job Description

• Provide Quality Engineering support for combination products, molding, assembly and automated manufacturing lines, and medical device operations.
• Ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and applicable global regulatory requirements.
• Participate in or lead risk management activities per ISO 14971, including DFMEA, PFMEA, hazard analyses, and control strategy development.
• Own and maintain Quality System documentation including work instructions, specifications, and control plans.
• Lead or support investigations for nonconformances, deviations, and customer complaints through root cause analysis using tools such as 5 Whys, Fishbone, Fault Tree Analysis, or DOE.
• Develop and implement effective Corrective and Preventive Actions (CAPA); verify and validate effectiveness.
• Monitor manufacturing risks and develop mitigation strategies focused on patient safety and product quality.
• Lead compliance efforts for handling scheduled drug products.
• Assist in training compliance DEA requirements

Qualifications

• Technical Knowledge: Proficiency in AutoCAD/SolidWorks, GD&T (Geometric Dimensioning and Tolerancing), and statistical software.
• Methodologies: Strong experience with Lean manufacturing, Six Sigma, and DMAIC (Define, Measure, Analyze, Improve, Control).
• Analytical Skills: Ability to interpret data, charts, and reports to drive improvements.
• Education/Experience: Usually requires a bachelor’s degree in engineering (Mechanical, Industrial, Chemical) and 5+ years of experience in regulated environments.

Additional Information

Benefits we offer:

• An innovative, vibrant and agile culture 
• Growth opportunities in a globally successful and dynamic business on a growth trajectory
• Excellent employee benefits including:
  • Medical, dental, vision, Life/AD&D, Short- and Long-Term Disability
  • Employee Savings Plan / 401k with 100% employer match