Quality Engineer
Quality Engineer
EPM Scientific has partnered with a globally renowned innovator in medical devices who are seeking an expert senior quality engineer to join their team. Recently, the company received FDA approval for its latest device focusing on diabetes, which offers unparalleled accuracy and convenience for glucose management. Be part of a team that is creating breakthrough technology to transform the lives of patients.
The Quality Engineer will be responsible for troubleshooting technical issues, providing timely customer feedback, and supporting the testing of new applications, among other duties. Moreover, they will document, and directly support technical evaluations and investigational tasks required for complaint processing/closure in a timely manner and in accordance with the team's procedures. They also will also interact with cross-functional teams such as Customer Support, Product Development, Engineering, Manufacturing, Sales, Regulatory, Clinical and other functional experts as needed to ensure clear understanding/investigation of applicable issues.
Job Info
- Frequently communicate with Customer Service team and troubleshoot escalated cases.
- Quickly identifying hardware and software solutions while managing multiple cases at the same time.
- Coordinate with Customer Service, Engineering, Quality, and any complaint investigation and analysis personnel to gather root cause determinations and properly document complaint closure.
- Support failure analysis of potential medical and field return complaint investigation using testing, standard lab processes and/or data analysis.
- Possible involvement with and/or support of internal and external audits of activities related to handling and documenting customer complaints.
- Maintain an understanding of information/data required to be collected for technical complaints to ensure compliance with regulations and directives.
Requirements
- Bachelors in Engineering or a Scientific field desired.
- 5+ years of experience in life science industry with 1-2 years of experience in medical device complaint documentation and processing preferred.
- Working knowledge of 21 CFR 820, 21 CFR 803, ISO-13485, ISO-14971, MEDDEV Vigilance Guidance
- Working knowledge of European Device Regulation (2017/745)
- The candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
- Excellent computer skills, including Outlook, Word, Excel, and Powerpoint
- Experience in a GMP and/or ISO regulated environment is preferred.
- Experience with technical/customer support software tools/databases.
- Ability to learn various and multiple software programs
- Ability to work in a cross-functional environment required.
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