Global Quality Digital Operations Engineer - Medical Device

Job Description Job Description Global Quality Digital Operations Engineer Medical Device Direct Hire Lakewood, CO (Hybrid) Salary Range: $125,000 to $157,000, plus benefits. Salary commensurate with experience JOB SUMMARY The Engineer Level 4 / 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 Bachelor’s degree in Engineering, Computer Science, or related field required. Master’s degree preferred. 8 years of global quality experience, preferably with a medical device company, but would consider pharma or biotech, so that candidate can contribute to process designs and workflows within ERP (QMS, Quality Management, Master Data Governance, Batch Release, Materials Management, Production Planning, Document Control, CAPA's, Investigations and Document Management System to support Quality operations.) 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 effectivelyacross 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 a valid passport International travel may be required Position is on-site in Lakewood, Colorado System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. Company Description System One is a leading provider of specialized, highly technical services and solutions to critical infrastructure, technology, life sciences, and government sectors. We partner with large private and public organizations who trust us to execute their complex, mission-critical initiatives through our outsourced services and workforce solutions. Company Description System One is a leading provider of specialized, highly technical services and solutions to critical infrastructure, technology, life sciences, and government sectors. We partner with large private and public organizations who trust us to execute their complex, mission-critical initiatives through our outsourced services and workforce solutions.