Quality Assurance Associate

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 a motivated and detail-oriented Quality Assurance Associate to join our team in a hybrid role supporting both hands-on quality-related R&D activities in the laboratory, manufacturing operations support, and assistance in the maintenance of quality systems and software tools. This position offers a unique opportunity to bridge the gap between scientific innovation and regulatory compliance, contributing to the development of high-quality products through cross functional collaboration.

Job Duties & Responsibilities:

Quality Support in R&D / Laboratory Testing / Manufacturing-Quality:

• May work in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Collaborate with R&D team to support quality-related testing activities during product development and overall product life cycle.
• Assist in product verification and validation processes, raw material and product testing, and documentation of lab results
• Assist in incoming inspection activities, in-process QA support and final acceptance activities.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Quality Assurance:

• Assist with the development, implementation and maintenance of quality systems, assuring that the QMS is in compliance with applicable standards and regulations, including cGMP, ISO 13485 and 21CFR Part 820.
• Assists in developing, applying and maintaining quality standards
• Track and generate non-conforming reports as required.
• Participate in other areas such as CAPA’s, deviations, change controls as required.
• Establish, monitor and evaluate quality system metrics.
• Assist in maintaining other Quality Systems such as the calibration system, CAPA’s, deviation, change controls and quality improvement activities as required.

Software & Data Management:

• Act as liaison between internal quality users and external software account managers to support effective use and maintenance of the electronic Quality Management System.
• Triage ad track user-reported issues, working collaboratively with software vendors to resolve system-related problems efficiently.
• Assist with the planning, documentation, and execution of software validation activities in accordance with regulatory requirements.
• Maintain software-related documentation, including validation protocols, risk assessments and overall system changes.
• Monitor system performance and participate in ongoing improvement of digital quality tools and workflows.

Job Requirements:

• High school diploma or equivalent required; relevant certifications or technical training a plus.
• 2-4 years of experience in a quality assurance, quality control or R&D support role, ideally within a regulated industry (e.g., biotech, pharma, or medical devices).
• Familiarity with quality regulations and standards (e.g., FDA, ISO, GMP).
• Hands-on experience with laboratory work an/or supporting quality activities in a lab setting.
• Excellent organizational skills and attention to detail.
• Excellent interpersonal skills and ability to work with others cross functionally.
• 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 a plus.

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.