Quality Engineer, Test Method Validation (TMV)

Company Description

medmix is a global leader in high-precision dispensing devices, holding leading positions in the healthcare, consumer, and industrial markets.

Our customers benefit from our strong focus on innovation and technological advancement, which has resulted in more than 900 active patents.

Headquartered in Baar, Switzerland, medmix operates 14 manufacturing sites worldwide. Together with our highly motivated and experienced team of nearly 2,700 employees, we are committed to serving our customers with uncompromising quality, close collaboration, and agility.

medmix is publicly traded on the SIX Swiss Exchange (SIX: MEDX). Visit www.medmix.swiss for more information.

Job purpose

Secure the success for medmix in the US and global markets by ensuring reliable, cost effective and efficient availability of medmix products and services.  The Test Method Validation (TMV) Quality Engineer is responsible for developing, validating, implementing, and maintaining test methods used to verify product quality and compliance with customer, regulatory, and industry requirements. This role ensures testing processes are accurate, repeatable, reproducible, and statistically sound.

Main accountabilities and tasks

• Contribute to risk assessments (FMEA, etc.) for equipment, processes, and test methods to proactively identify and mitigate compliance and operational risks.
• Independently draft and execute complex validation plans, protocols, and test strategies (TMV) to ensure compliance and expedited release of critical site equipment
• Design, write, and execute TMV (Test method validation) protocols for new and modified test methods and equipment.
• Perform measurement system analysis (MSA), Gauge R&R, and capability studies to quantify testing variability and ensure repeatability.
• Ensure design transfer readiness by standardizing the verification of critical quality attributes, critical process parameters, and control strategies by proper definition, validation, and documentation.
• Balance competing priorities while ensuring global work is conducted per regulatory requirements and company procedures
• Serve on internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality-related issues and support continuous improvement
• Train personnel in quality and TMV principles
• Support Engineering and Metrology in the selection, review, acquisition, and upgrade of systems, production equipment and analysis as required
• Share quality philosophies throughout Operations and support Production and Engineering
• Perform all company business in accordance with regulations (EEO, FDA, etc.) and company policies
• Develop audit responses and complete CAPAs by target due dates; ensure Validation areas are "inspection ready" at all times
• Execute actions required to support Change Control, Deviation, and CAPA on-time closure
• Ensure testing methods meet industry standards (e.g., ISO, FDA), and maintain an airtight evidence trail for regulatory audits.
• Validate test equipment, fixtures, and software used in the lab to guarantee they produce defect-free, consistent data.
• Identify root causes of test method failures and modify testing methods or objectives to resolve anomalies.
• Work alongside R&D, manufacturing, and quality teams to ensure that new product designs are fully testable.

Desired experience and qualifications

Work experience:

• +4 years of experience in a GMP manufacturing/production environment
• +3 yeas of experience in Metrology including calibration, MSA, TMV and supporting validation activities to ensure accuracy, compliance and data integrity

Education: Bachelor’s degree in Engineering, Quality Management, Manufacturing, or related field. 

Technical skills: Knowledge and ability to conduct quality tools and methodologies, including:

• SPC (Statistical Process Control)
• FMEA (Failure Mode and Effects Analysis)
• MSA (Measurement System Analysis)
• TMV (Test Method Validation)
• Root Cause Analysis
• Lean Manufacturing and Six Sigma principles
• Experience with quality management systems and audits.
• Strong proficiency with statistical software like Minitab or JMP to analyze data and define acceptance criteria.

Core competences:

• Strong analytical and problem-solving skills.
• Ability to make decisions regarding product acceptability based on documentation
• Demonstrated ability to work with diverse groups and manage conflict
• Proficiency in Microsoft Office and quality data analysis tools.
• Excellent written and verbal communications skills
• Ability to plan, schedule, organize, prioritize, and coordinate project activities  
• Ability to function in a leadership role and within cross-functional team

Languages: English

medmix is an equal opportunity employer committed to the strength and value of a diverse workforce.

93% of our employees go above and beyond to achieve results. Do you have the drive to succeed?

Join us and take the next step in your career, starting today!