Ingnieur QualificationValidation
Ingnieur QualificationValidation
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Job Description
At Stryker were not just building medical deviceswere improving lives. As a Fortune 100 company recognized among the top workplaces in Europe we are united by one mission:
Together with our customers we are driven to make healthcare better.
As part of our Global Quality Operations QA Validation team youll play a critical role in ensuring our systems and processes meet the highest standards of safety performance and compliance. If you thrive in collaborative crossfunctional environments and bring both precision and curiosity to your workthis is your opportunity to make a real difference.
Your mission:
Lead Validation Projects: Plan execute and document Equipment Qualification (EQ) Computer System Validation (CSV) and qualification of Buildings Facilities Utilities (BFU) in alignment with global and local standards.
Collaborate CrossFunctionally: Work closely with global and local teams across multiple functions to support validation strategy and process optimization.
Document Meticulously: Author validation deliverables (FAT SAT IQ OQ EQ MSA) within our eVLMS (ValGenesis) maintaining a clear and compliant validation lifecycle.
Apply Engineering Best Practices: Use quality engineering tools process development methods and statistical analysis to ensure every process delivers consistent reliable results.
Evaluate and Analyze: Run process and equipment tests analyze data and ensure validation outcomes meet regulatory and internal requirements.
Contribute to Continuous Improvement: Support remediation projects and ongoing process development by proactively identifying areas for improvement.
Champion Quality and Compliance: Help ensure Stryker maintains its reputation for worldclass quality by upholding FDA ISO and GMP standards.
Build Knowledge and Share It: Stay informed on regulatory and technological developments and contribute to a culture of learning safety and innovation.
Your profile:
Bachelors degree in Engineering Medical Science Quality or related fields
Familiarity with FDA ISO and GMP standards
Strong understanding of validation methodologies and statistical tools such as sampling plans Gage R&R and process capability
Experience with validation documentation and lifecycle systems (e.g. ValGenesis)
Strong interpersonal and communication skillsable to collaborate across cultures and disciplines
Proficiency in French (written and spoken) and professional English
Employment Type
Full-Time
