Sr. Quality Engineer

at  Pramand LLC

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:

We are seeking an experienced Senior Engineer to join the Quality Assurance team. This individual will manage day-to-day quality control, quality engineering and document control activities. You will be responsible for planning activities concerned with application and maintenance of quality standards and overall quality system, and development of procedures for qualification of manufacturing processes, materials and products. Resolve quality problems and improve areas of high quality costs. Monitor and report on facility quality systems and programs. Represent quality interests and concerns on project teams. The position is set in a fast-paced start-up environment and requires the individual to work on a broad range of tasks.

QUALIFICATIONS & REQUIREMENTS:

• Bachelor’s degree in scientific/engineering or relevant discipline
• Five to eight years medical device industry experience in quality function.
• Thorough understanding of QSR, EU (MDR) and applicable regional and/or local regulations, the MDR and requirements pertaining to CE marking.
• Thorough knowledge of product development process and design control.
• Technical background, scientific judgment, exhibit initiative.
• Knowledgeable in application of quality principles and industry guidelines for quality systems.
• Solid understanding of risk management and statistics.
• Strong communication skills.
• Ability to conduct an audit and to undergo audit.
• Excellent interpersonal skills and ability to motivate others who are not in the department.
• Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
• Excellent organizational skills and attention to detail.
• ASQ certification (i.e., CQA, CQE) a plus.
• Ability to think critically and problem solve.
• Willingness to collaborate with the team and work well with others.

Working Conditions & Physical Requirements:

• Duties of this position are generally performed in good working conditions.
• Occasional exposure to elements such as noise, dust, chemicals, operating machinery, temperature extremes, etc.
• Long periods of time working at a computer.
• The ability to perform detailed visual and physical inspection of products.

• Assure that the Quality System is in compliance with applicable standards and regulations, including cGMP, CMDR, ISO 13485:2016, and ISO 14971:2019.
• Perform and/or participate in facility internal and external audits and oversee complaints program. Responsible to assist in other areas of the Quality Management System as things arise.
• Responsible for reviewing and approving document change controls.
• Lead the Risk Management and Design Control process for certain product lines: Interface with R&D to ensure that products are designed for patient safety in terms of FMEA, hazard analysis, Quality System compliance and manufacturability.
• Develop, refine and document quality control test and inspection procedures.
• Support activities related to product verification and validation processes.
• Ensure data integrity by implementing statistical techniques to inform testing.
• Support implementation of sterility and biological test/validation requirements.
• Coordinate and assist in the qualification of internal and external manufacturing operations.
• Perform inspections and testing of commercial and development products
• Perform other quality engineering duties when requested.