Quality Engineering & Assurance

Quality Engineer II
Pramand, LLC, is a medical device company based in Bedford, MA. We develop implantable medical devices from novel, proprietary hydrogel materials that improve patient outcomes while lowering the cost of therapy. We self-fund our projects through preclinical development and work with financial partners for clinical development and commercialization. Our portfolio of hydrogel technology positions us to be the leader in creating new hydrogel based medical devices to address unmet medical needs in a range of surgical interventions. We have launched over ten medical device companies based on this unique technology. These companies have generated over $4B in value and have helped over 5 million patients worldwide achieve better outcomes.
The Quality Engineer II is an intermediate level role. They will serve as a technical team member performing day-to-day quality assurance, quality control and quality engineering activities for medical devices. This individual will be involved with leading technical aspects of low complexity projects, supporting manufacturing, participation in operational excellence and quality documentation.
Manufacturing Quality Support

Develops, implements, and maintains quality standards and inspection protocols for raw materials and manufacturing processes.
Conduct and document incoming, in-process, and final inspection activities.
Provide real-time QA support to manufacturing operations, including inspections, inventory control, document reviews, and quality issue investigations (root cause analysis).
Identify possible sources of manufacturing defects and assisting in dispositioning of non-conforming material.
Identify, implement, and manage equipment calibrations to support production goals
Partner with manufacturing and R&D teams to ensure robust process controls and adherence to quality standards.
Support quality assurance initiatives in areas such as design controls, qualifications, and validation activities.
Quality System & Compliance

Support quality system functions such as non-conformance reporting, CAPA (Corrective and Preventative Actions), complaint handling, calibration control, and environmental compliance.
Track, analyze, and report on key quality metrics to drive continuous improvement initiatives
Customer / supplier liaison contact
Performs additional quality duties as assigned
Bachelor's degree in scientific/engineering or relevant discipline or equivalent work experience.

• 2-4 years of experience in a regulatory and/or controlled environment, i.e. medical device, pharmaceutical, biomedical industry or a diagnostic laboratory setting.
• Must have a strong technical background, scientific judgement, customer focus, exhibits initiative.
• Self-oriented, self-organized and able to work with minimum supervision.
• Computer literacy, proficiency in MS Office, Excel, PowerPoint etc.
• Knowledgeable in application of quality principles and industry guidelines for quality systems.