Transonic, a leader in innovative volume flow measurement technologies, seeks a dynamic, critical-thinking, and self-directed initiator to join our Quality Assurance department. This role is crucial in ensuring the quality of our diverse product offerings for medical devices, life sciences, and OEM markets. The ideal candidate will possess a solid understanding of quality management principles, including ISO 13485 and MDSAP requirements, and will play a pivotal role in maintaining the company's compliance with these standards. We are searching for a team member who thrives in a fast-paced environment, is detail-oriented, can effectively prioritize projects, and is forward-thinking in identifying opportunities for improvement within our quality systems.
Core Duties and Responsibilities
- Manage the Corrective Action Board functions, including leading the weekly CAB meeting, following up with CAPA leaders on process, extension requests, and various VAPA stages, and ensuring timely completion of CAPAs throughout the company.
- Performing solo CAPA management for relevant Quality CAPAs including Failure investigations, verification of effectiveness, implementation, and any needed training as a result of the CAPA activities.
- Engage in and support major and minor internal and external audits, enter findings in the QMS’s Audit & CAPA modules, and ensure corrective actions are carried out in a timely manner and are in compliance with relevant ISO, FDA, and MDR requirements.
- Initiate engineering change orders to correct drawings, specifications, and Quality System Process/Procedures, and manage/reconcile issues with the document control system including the QMS and its related Work Instruction System.
- Assess and document reportability decisions for incoming customer complaints and follow through on complaints from assessment to failure analysis to closure.
- Initiate and facilitate continuous improvement projects for Quality Systems and support continuous improvement efforts from other departments as needed.
- Support the QA team with other work-related duties as requested, directed or assigned by management.
Education and Experience
- A minimum of a BS in Engineering or related professional field is required.
- 3+ years of experience in quality engineering is preferred.
- Prior experience in a medical device or other highly regulated environment is preferred.
- Experience with electrical component inspection and assembly is a plus.
- ASQ Certification (CQE, CQA, CMDA, CSSBB) is a plus.
