Staff Digital Quality Systems Engineer (temporary position)

Smith & Nephew · Alajuela

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Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.   

Are you looking for a new opportunity where you can develop yourself?

The Staff Digital Quality Systems Engineer serves as an operational extension of the Global eDHR Product Owner and Windchill PLM Quality Business Process Owner. The role supports the development, deployment, governance, and continuous improvement of enterprise Digital Quality Systems.

This role drives process harmonization, compliance, stakeholder alignment, and adoption of global quality system capabilities supporting manufacturing operations and product lifecycle management and operates within a highly matrixed global environment supporting enterprise-wide Digital Quality transformation initiatives. Success requires balancing strategic objectives with operational support while driving standardization across multiple sites, functions, and technologies.

The role influences stakeholders across Quality, IT, OT, Manufacturing, Engineering, and R&D while ensuring compliance with regulatory and business requirements. The role operates within a demand-to-delivery Scaled Agile process to ensure program initiatives are properly assessed, defined, and prioritized for development.

This is a temporary 12-month contract role.

What will you be doing?

• Coordinate system enhancements, releases, issue resolution, and stakeholder alignment.
• Interprets disparate business processes, proposes harmonized processes across business units, and drives standardization. throughout the enterprise. Applicable to both EDHR and PLM projects.
• Lead deployment, training, communication, and adoption activities globally.
• Support enterprise eDHR and PLM strategy, governance, and roadmap execution.
• Lead process creation for change control and lifecycle management processes.
• Ensure data integrity, compliance, audit readiness, and regulatory alignment.
• Defines features and initiatives to enable the EDHR program across all internal S+N manufacturing sites.
• Assesses impact to the global business to determine which features and initiatives should be prioritized.
• Acts as business process owner for assigned features and initiatives.
• Defines business requirements and ensures technical solutions appropriately solve business process needs. Applicable to both EDHR and PLM projects.
• Facilitate workshops and cross-functional decision-making forums.

This position is P4 level 

What will you need to be successful?
Education: Bachelor degree in Engineering, Life Sciences, Quality, Computer Science, or related technical discipline.
Experience: 7+ years supporting Quality Systems in regulated industries.

• Knowledge of FDA 21 CFR Part 820/11 and ISO 13485.
• Experience developing GxP computer systems requirements and assessing. digital solutions.
• 2+ years in roles supporting a manufacturing environment.

Competencies: Quality Systems Management, Digital Transformation, Change Management, Business Process Ownership, Stakeholder Management, Data Integrity, Continuous Improvement

Skills: eDHR; PLM; Windchill; Tulip; Agile/Scrum; Jira; Change Control; Document Control; Data Integrity; Validation Lifecycle; Project Management; Process Improvement; Root Cause Analysis; Stakeholder Management

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/ 

• Your future:  stock purchase program, referral bonus, subsidy in transport and food, recognition program.
• Work/Life Balance: Extra days off, birthday off, voluntary hours.
• Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave. 
• Flexibility: Hybrid work model (for more professional roles), flexible schedules.
• Training: Training program, unlimited learning.
• Extra perks: employees association, and more…

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