About this opportunity
Commonwealth Sciences, Inc. lists this Quality Engineer (ISO 13484) opportunity in boston, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Provide quality oversight and support for combination product development and commercialization activities.
Maintain and support the Quality Management System (QMS) in compliance with ISO 13485, 21 CFR Part 820, 21 CFR Part 4, and other applicable FDA and international regulations.
Partner with R&D, Engineering, Manufacturing, Regulatory, and Clinical teams to ensure quality requirements are incorporated throughout the product lifecycle.
Support Design Control activities, including Design History File (DHF) documentation, design reviews, design verification and validation, and design changes.
Assist with risk management activities, including product risk assessments, FMEAs, and implementation of risk controls.
Review and approve quality and technical documentation, specifications, protocols, reports, and change controls.
Support investigation of nonconformances, deviations, complaints, and CAPAs, including root-cause analysis and effectiveness checks.
Participate in supplier qualification, supplier quality activities, and oversight of external manufacturing partners.
Support internal and external audits and assist with preparation of responses to audit findings.
Provide quality guidance to cross-functional project teams and help identify potential compliance risks early in the development process.
Contribute to continuous improvement initiatives related to product quality, processes, and the overall QMS.
Requirements
Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical field.
3+ years of experience in Quality Engineering within medical device, pharmaceutical, biotechnology, or combination product environments.
Working knowledge of ISO 13485, FDA 21 CFR 820, and 21 CFR Part 4.
Experience with Design Controls, risk management, CAPA, nonconformance investigations, and change control.
Experience working in a regulated GMP environment preferred.
Strong technical writing, documentation, problem-solving, and communication skills.
Ability to work effectively with cross-functional teams in a fast-paced product development environment.
Internal Job ID 10577
IND1
#J-18808-Ljbffr
Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.