Global Quality Digital Operations - Engineer 4 - SAP S4 Hana

JOB TITLE: Global Quality Digital Operations – Engineer 4 – SAP S4 Hana

JOB SUMMARY

The Engineer Level 4 – SAP S/4HANA Quality Engineer is a senior technical role responsible for driving the Quality workstream of the S/4HANA transformation. The role requires extensive Quality engineering knowledge, advanced SAP expertise, and the ability to solve complex technical challenges in a regulated environment. The role will be responsible for and lead strategic initiatives involving SAP configuration, data integrity, and cross-functional process integration for the S4 implementation.

This position offers the opportunity to influence system architecture, improve operational efficiency, and support compliance across global teams.

ESSENTIAL DUTIES

• SAP S/4HANA Configuration & Optimization: Lead the setup, customization, and continuous improvement of SAP S/4HANA modules such as Quality Management, Master Data Governance, Batch Release, Materials Management, Production Planning, and Document Management System to support Quality operations.
• Regulatory Compliance Support: Ensure SAP processes and documentation align with FDA, ISO 13485, and other global medical device regulations.
• Data Governance & Security: Maintain high standards of data accuracy, traceability, and security within SAP systems, supporting audit readiness and regulatory inspections.
• Change Control & Documentation: Manage engineering change workflows and technical documentation within SAP, ensuring consistency and traceability across departments.
• Cross-Functional Collaboration: Partner with Process Engineering, Finance, Regulatory, and Operations teams to align SAP capabilities with business needs and technical requirements.
• Project Leadership: Lead SAP S/4 transformation, module update rollouts, and process redesigns. Provide technical direction and mentorship to junior staff.
• Engineering Integration: Apply Quality engineering principles to enhance SAP workflows that support design, validation, and manufacturing processes.
• Training & Support: Provide training and ongoing support to SAP users across departments. Develop best practice guides and troubleshoot system issues.
• Process Improvement: Identify and implement improvements to SAP workflows that enhance efficiency, compliance, and user experience.
• Reporting & Analytics: Collaborate on dashboards and reports to monitor system performance, data quality, and operational metrics.

OTHER DUTIES AND RESPONSIBILITIES

• Provide work direction to technicians and junior engineers.
• Collaborate with manufacturing and regulatory teams on compliance and operational issues.
• May contribute to business planning, budgeting, and strategic goal setting.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree in Engineering, Computer Science, or related field required.
• Master’s degree preferred.

Experience

• Minimum 8 years of engineering or ERP systems experience.
• 5+ years of SAP experience, including full-cycle S/4HANA implementations.

Skills

• SAP S/4HANA Expertise: Advanced knowledge of SAP modules including MM, PP, QM, and DMS.
• Familiarity with SAP related technologies (e.g., Activiate, Magnitude Angles) a plus.
• Ability and willingness to manage multiple workstreams simultaneously and prioritize effectively across multi-site, global rollouts and legacy system integrations.
• Regulatory Knowledge: Familiarity with medical device regulations and their application within ERP systems.
• Technical Documentation: Skilled in managing engineering documentation and change control within SAP.
• Problem Solving: Ability to troubleshoot SAP-related issues and implement effective solutions.
• Collaboration: Experience working across departments to align SAP processes with business needs.
• Training & Mentorship: Capable of educating users and mentoring team members on SAP functionalities.
• Communication: Strong verbal and written communication skills; able to present complex technical information clearly.

OR

• An equivalent competency level acquired through a variation of these qualifications may be considered.

Additional Requirements

• Must possess or be willing to acquire valid passport
• International travel may be required
• Position is on-site in Lakewood, Colorado

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.