Quality Engineer (Medical Device, Pharmaceutical)

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.

Salary : $140,000 - $150,000