Medical Device - Quality Engineer in Cambridge

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Job DescriptionJob DescriptionOur client is seeking a highly detail-oriented and adaptable Quality Engineer to lead and execute quality initiatives across product development, manufacturing, and supplier operations. This role serves as the primary on-site quality representative, working closely with senior leadership to ensure consistent execution, strong compliance, and high product standards.
Responsibilities:
Develop, qualify, and maintain test methods and associated tooling Execute verification and validation activities, including protocol/report Perform statistical analyses (e.g., Gage R&R, DOE) using tools such as Minitab
Perform incoming inspections (including AQL), labeling, and packaging checks Support supplier selection, qualification, and ongoing quality management Collaborate with internal teams and external partners to ensure robust manufacturing and inspection processes Contribute to design history documentation, including risk management and verification activities Conduct in-process and final inspections, including record review Support investigations, root cause analysis, and corrective/preventive actions Participate in sterilization-related reviews as needed
Maintain document control, traceability, and quality records Support and enhance the Quality Management System (QMS) Ensure compliance with applicable regulations and standards (e.g., ISO 13485, FDA requirements)
Partner with engineering and operations teams to integrate quality throughout development Support design controls, design transfer, and product release readiness Identify risks and proactively drive continuous improvement initiatives
Requirements:
Bachelor’s degree in engineering 5+ years of hands-on experience in the medical device industry (Class II or III ) Experience with quality systems, design controls, and supplier quality management Strong skills in test method development, risk management, and root cause analysis (e.g., FMEA, 5 Whys) Proficiency with statistical analysis tools (e.g., Minitab or equivalent) Familiarity with ISO 13485, ISO 14971, and FDA quality system regulations High level of attention to detail and documentation rigor Ability to work independently in a fast-paced environment
:
Combined R&D and quality engineering experience Experience with complex or implantable medical devices Familiarity with sterilization processes and validation Experience in minimally invasive or precision device manufacturing
Pay $46 - $65 / hour W2 Depending on experience
#INDENG #ZREng Company DescriptionWe are the experts in Human Capital. It starts with a commitment to personal attention. A single point of contact from day one. That's what makes The Panther Group different. That is how we deliver results to our clients and candidates. Our focus on quality, and service sets us apart. At The Panther Group, it's about attention to detail. We attract the right talent, connect job seekers with the right jobs and provide the right custom solutions because we worry about the little things. Providing our clients the best value for their dollar, finding our job seekers opportunities where they can thrive, giving our clients and candidates the level of service they deserve, leveraging the most efficient processes in the industry.Company DescriptionWe are the experts in Human Capital. It starts with a commitment to personal attention. A single point of contact from day one. That's what makes The Panther Group different. That is how we deliver results to our clients and candidates. Our focus on quality, and service sets us apart. At The Panther Group, it's about attention to detail. We attract the right talent, connect job seekers with the right jobs and provide the right custom solutions because we worry about the little things. Providing our clients the best value for their dollar, finding our job seekers opportunities where they can thrive, giving our clients and candidates the level of service they deserve, leveraging the most efficient processes in the industry.
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
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Location:
Cambridge
Job Type:
FullTime
Category:
Engineer, Quality Engineer, Quality, Engineering

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