Quality Engineer, Test Method Validation (TMV)

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.

Qualifications :

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: Bachelors 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

Additional Information :

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

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Remote Work :

No

Employment Type :

Full-time