Quality Engineer II
About The Position
The Quality Engineer II serves as a member of our production support team for complex electronic and software based medical devices. This role is part of the technical writing, decision making, and customer facing portion of the operations quality team and supports both the New Product Introduction (NPI) and commercial sides of the business. Routine activities fall into the categories of change management, non-conformance management, and partnership with the development teams. Communication and collaboration with customers is required when applicable. This position plays a critical role in incorporating quality into processes and ensuring ongoing compliance with established quality management systems.
Requirements
- Bachelor’s degree in an engineering, technical, or scientific discipline
- At least 2 years of relevant experience; medical device preferred
- Experience in technical writing & presentation of engineering-based investigations
- High proficiency in use of standard electronic business tools: Outlook, Word, PowerPoint, Excel, Visio.
- Effective communication skills to provide technical feedback internally and clear guidance / updates to external customers.
- Ability to evaluate risk and impact of changes and non-conforming conditions and make data driven decisions.
- Passionate for change and continuous improvement and embodying a strong sense of urgency.
- Must be authorized to work in the United States.
Responsibilities
- Author, consult, and approve product and system quality related content to ensure risk-based evaluation of Engineering Change Orders, CAPAs, and planned deviations.
- Complete DHR review and formal written responses to customer feedback / complaints; collaborate on SCAR investigations and development of appropriate corrective and / or preventive actions.
- Review and approve re-work logs and non-conforming material reports, provide or confirm dispositions as required.
- Develop Manufacturing Control Plans, Master Validation Plans, and PFMEAs; support development of Validation / Qualification protocols.
- Collaborate with a variety of engineering organizations to ensure a consistent approach to incorporating compliance to quality management systems within production processes.
- Address manufacturing cell escalations as they are raised through the operations quality organization.
- Identify continuous improvement opportunities to improve the efficiency of quality management system processes.
- Support internal quality audits, as required by the annual schedule.
- Serve as the Quality point of contact with customer organizations, as required.
- Other duties as assigned.
Benefits
- health, dental, vision, 401K plans, and time off programs
- annual bonus program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
