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Please note I have direct access to the Hiring Director on this position. Compensation: Base Salary + Bonus: 10% + Relocation Assistance
We are the leading Global Biotech Company in our niche and are looking for a Quality Engineer. We have been in business for 50+ years, are publicly traded, have 7+K global employees, recognized $6.6 billion in revenues (7% increase over previous year), $153 million in profits (32% increase over previous year), have 750+ product patents, released 6 new products in in the past year and are an active philanthropic institution.
This role functions as a hybrid Quality Engineer and SAP Business Analyst, specifically focused on the quality elements and regulatory integrity of the ERP system. The candidate will not perform technical configurations but must possess a deep functional understanding of how medical devices move through SAP, specifically within Supply Chain and Finance workstreams. Coming from a Quality Department background in a regulated environment, this individual will ensure that system workflows for CAPA, batch records, and engineering changes remain compliant with global medical device regulations.
Responsibilities:
- Provide regulatory compliance support by ensuring all SAP processes and system documentation align with FDA, ISO 13485, and other global medical device standards.
- Manage engineering change workflows and technical documentation within SAP, maintaining strict consistency and traceability across all internal departments.
- Oversee the quality elements of the system, including the management of CAPA (Corrective and Preventive Actions) and the movement of electronic batch records through the system.
- Partner with Process Engineering, Finance, Regulatory, and Operations teams to align SAP system capabilities with evolving business needs and technical requirements.
- Apply established Quality Engineering principles to enhance SAP workflows that support product design, validation, and manufacturing processes.
- Identify and implement continuous improvements to SAP workflows to drive efficiency, compliance, and an improved user experience.
- Develop detailed user specifications and write requirements for how processes should function within the ERP environment.
- Analyze and document how various SAP modules interact, focusing on the integration between Supply Chain and Finance.
Requirements:
- Professional background within a Quality Department of a medical device or pharmaceutical company is highly preferred.
- Deep understanding of medical device regulations (FDA 21 CFR Part 820, ISO 13485) and their application within an automated system.
- Strong knowledge of ERP systems (SAP preferred) with the ability to map the physical movement of goods to digital system transactions.
- Functional expertise in Supply Chain and Finance modules, including an understanding of how these workstreams intersect in a manufacturing environment.
- Demonstrated ability to develop user specifications, workstream documentation, and process requirements.
- Experience managing technical documentation and engineering change control processes.
- Strong collaborative skills to work across Process Engineering, Finance, and Regulatory teams.
- Experience in any of the following are only a Plus; NOT mandatory Prior experience participating in or completing a full-lifecycle SAP implementation and reporting experience with Custom SQL, Power BI, Magnitude Angles (Every Angle), etc..
Benefits
Company offers a comprehensive benefits package including: 6% matching 401K (immediately vested); 5 Weeks PTO, HMO/PPO Medical, Dental, and Vision coverage for employees; paid company holidays, flexible spending plans/HSA, tuition reimbursement and a casual work environment.