Senior Quality Specialist – CSV

Join to apply for the Senior Quality Specialist - CSV role at Smith+Neu.

Life. Unlimited. At Smith+Neu 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?

• 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

Benefits

At Smith+Neu 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 a 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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Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing

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