Quality Engineer I

About Us:

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.

Position Summary:

The Quality Engineer I will assist in performing day-to-day quality assurance, quality control and quality engineering activities for medical devices. They will be involved with supporting manufacturing, participation in operational excellence and quality documentation. 

Job Duties & Responsibilities:

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.

Design & Development Support:

• Support product verification and validation activities, including testing for new product development and sustaining programs.
• Support quality assurance initiatives in areas such as design controls, qualifications, and validation activities.
• Support changes to design specifications 

Quality System & Compliance:

• Assist in maintaining compliance with internal procedures and external standards and regulations, including cGMP, ISO 13485 and 21CFR Part 820.
• 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.

General:

• Collaborate with cross-functional teams to drive issue resolution and implement effective corrective and preventative measures.
• Performs additional quality duties as assigned.

Job Requirements:

• Bachelor’s degree in scientific/engineering or relevant discipline or equivalent work experience.
• 0-2 years of experience in a regulatory and/or controlled environment, i.e. medical device, pharmaceutical, biomedical industry or a diagnostic laboratory setting. 
• Familiarity with FDA QSR and/or ISO 13485 requirements.  
• Excellent organizational skills and attention to detail. 
• Excellent interpersonal skills and ability to work collaboratively in a cross-functional team setting. 
• Technical background, scientific judgement, exhibits initiative. 
• Knowledgeable in application of quality principles and industry guidelines for quality systems.  
• Strong communication skills, problem solving and time management skills. 
• Computer literacy, proficiency in MS Office, Excel, PowerPoint etc. 
• Self-oriented, self-organized and able to work with minimum supervision.  
• Experience working in clean room preferred. 

Working Conditions:

• Physical demands required to perform testing/inspections, includes the ability to lift 25 pounds, perform visual inspections, test samples on an electromechanical testing machine, etc.
• Long periods of time working on a computer.