Senior Quality Specialist - CSV

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 Smith & Nephew’s global quality framework, supporting the implementation and ongoing life cycle of GxP systems from initial deployment through maintenance to retirement. You’ll provide QA oversight, guide business partners on regulatory compliance, and support the development and rollout of global Computer Software Assurance (CSA) policies, procedures, and training initiatives.

In this role, you’ll promote alignment across the organization by communicating activities, results, and requirements, sharing industry benchmarks and best practices, and participating in communities of practice (CoP) to drive continuous improvement of systems and processes. You’ll also develop strong relationships within the organization, particularly across IT and Quality Operations, and become a trusted internal business partner.

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:

• 3–5 years’ experience in the medical device or pharmaceutical industry, supporting Computer Software Validation (CSV) and System Life Cycle (SLC) projects in validation or quality oversight roles.

• Knowledge of global standards and regulatory requirements for GxP, Data Integrity, CSA, CSV, and International Electronic Records & Electronic Signature regulations.

• Familiarity with software development best practices, including GAMP, ISO, IEEE, CMMI, requirements engineering, testing, configuration management, change management, auditing, and Agile methodology.

• Experience with validation of life sciences systems such as SAP, Veeva, or similar; experience with Change Management and ServiceNow is a plus.

• Strong written, oral, interpersonal, and organizational skills with a proven track record of delivering tasks on schedule.

• Ability to understand the impact of external regulations and standards on quality processes and systems.

• Broad understanding of CSA/CSV, Quality Systems, and processes across the product lifecycle; professional certifications such as ASQ CSQE are desirable but not required.

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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