What are the responsibilities and job description for the Quality Engineer II position at TALENT Software Services?
Description:
About This Role:
Responsible for creating test methods, work instructions, training, and mentoring technicians who work on the nvestigation of return and non-return products. The QE will review the results of investigations completed by others for accuracy, completeness, and compliance with SOPs/WIs. The results of investigations can be used to escalate product issues in collaboration with other Post Market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety.
Your Responsibilities Will Include:
Minimum Qualifications
About This Role:
Responsible for creating test methods, work instructions, training, and mentoring technicians who work on the nvestigation of return and non-return products. The QE will review the results of investigations completed by others for accuracy, completeness, and compliance with SOPs/WIs. The results of investigations can be used to escalate product issues in collaboration with other Post Market functions, R&D, Design Assurance, Operations, Supplier Management, and Medical Safety.
Your Responsibilities Will Include:
- Understanding failure modes and approving product analysis for return and non-return complaints related to mechanical medical devices performed by technicians
- Coordinating, training, and supervising failure investigation activities for lab technicians
- Support integration of new products into CIS lab by creating/validating test methods and test instructions
- Creating and presenting slides for SER/CRB
- Collaborating with other Post Market (CCC/CMC) teams, R&D, Design Assurance, Manufacturing, and Supplier to help determine the root cause of complaints
- Monitoring product performance and escalating any non-conformance issues with returned devices
- Creating and releasing new WI/SOPs in the document control system
- Initiating and owning non-conformance investigations
- Training technicians to find the root cause of complaints through sound failure analysis techniques
Minimum Qualifications
- Bachelor's degree in Mechanical Engineering with 2 years of relevant experience
- Bachelor's degree can be in electromechanical/electrical, but the candidate needs to have hands-on experience in failure analysis.
- Demonstrated problem-solving & failure analysis capabilities of mechanical systems/components
- Proficient with Microsoft Office tools, including Word, Excel, PowerPoint, and Outlook
- Great written/verbal communication skills and ability to collaborate with other teams
- Ability to successfullymultitaskk and be adaptive
- Master's degree in Mechanical Engineering with at least 1 year of experience in a similar role
- Ability to understand system-level functionalities, to devise and validate test methods for failure analysis of systems/components
- Experience in the Medical Device industry
- Familiarity with Post Market requirements and systems
- Familiarity with complaint systems used for medical devices
- Experience with using SAP and Power BI
Salary : $45 - $50