Senior Quality Engineer- IVD/ Medical Device
Business Unit: Laboratory Diagnostics
Requisition Number: 236789
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 5%
Siemens US Talent Acquisition
An experienced mid-senior level Quality Engineering position at Walpole, which is involved in developing, implementing, maintaining, and improving systems to ensure products are designed and produced to meet or exceed customer requirements and expectations. The candidate ensures consistent implementation and compliance to the Siemens Healthcare Diagnostics Quality System and external regulations including, but not limited to, the FDA Quality System Regulation (21 CFR Part 820), ISO 13485 and In-Vitro Diagnostics Directive (IVDD).
- Quality Engineer (QE) establishes the principles of product quality evaluation and control for the system.
- The QE provides independent oversight and review of the project deliverables throughout the lifecycle; participates in the change management process to ensure the products continue to meet customer requirements; and is part of a cross-functional team with other business and engineering disciplines.
- The Walpole QE’s work-scope includes Quality Engineering support for the Design Changes, Process Changes, New Product Design Transfer, Process Validation, and Risk Management Process.
- The main functions of the QE also include acting as the quality representative on the element team during technical transfer from design to manufacturing and to support changes going forward after manufacturing has commenced.
- The individual is a team player participating on design transfer project teams to provide leadership in the design control, process validation and control, and risk management process in a class II and class III IVD reagent manufacturing facility. Challenges include working among different business units within the company.
Required Knowledge/Skills, Education, and Experience
· BS in Life Science or Engineering discipline with a minimum of 5 years of experience in the medical device, pharmaceutical or biotechnology industry.
· Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Process Validation; Design Control; ISO 13485; and ISO14971.
· Proven experience providing quality engineering leadership to project teams in the areas of Design Controls, Process Validation, and Risk Management.
Preferred Knowledge/Skills, Education, and Experience
· Trained on Quality System Regulation, Process Validation, Risk Management or Design Control course
· Experienced with New Product Development, Equipment Qualification and Process Validation
· ASQ Certified Quality Engineer
· Demonstrated and applied a broad knowledge of field of specialization through successful completion of moderately complex assignments