Smith+Nephew

Senior Quality Specialist - CSV

POL - Wroclaw Full time
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

Are you passionate about quality and compliance in a global environment? This is your opportunity to join a team that shapes the future of medical technology by ensuring our systems meet the highest standards. If you thrive on collaboration and want to make a real impact, read on.

What will you be doing?

You’ll be at the heart of our global quality framework, supporting the development and maintenance of a robust Computer System Validation (CSV) and System Life Cycle (SLC) program. From implementation to retirement, you’ll provide QA oversight for GxP systems, align global policies and best practices, and guide business partners on regulatory compliance. You’ll share insights, promote continuous improvement, and become a trusted partner across IT and Quality Operations.

What will you need to be successful?

Success in this role means being a proactive problem solver and a strong communicator who can navigate complex regulations and systems. You’ll bring:
  • A Bachelor’s degree and 3–5 years’ experience in the medical device or pharmaceutical industry
  • Hands-on experience with computer software validation and SLC projects
  • Knowledge of global standards for CSV and regulatory requirements for GxP, Data Integrity, and electronic records/signatures
  • Strong organizational and interpersonal skills with a proven ability to deliver on schedule

At Smith+Nephew we offer

Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about our Employee Inclusion Groups on our website 

Your Future: annual bonus, life insurance, company stock saving plan 

Work/Life Balance: paid volunteering hours, flexible approach 

Your Wellbeing: private health care with dental care package, multisport card/my benefit platform 

Flexibility: possibility of working in hybrid model 

Training: Hands-On, Team-Customized, subsidies for language classes, certifications and postgraduate studies 

Extra Perks: referral bonus, recognition program, mentoring program 

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