Quality Engineer

The position is listed below-Position: Quality Systems Engineer (QSE)Location: Acton, MA (Onsite)Duration: Long-term contract Experience: 5+ yearsRole Overview:We are currently hiring for Quality Systems Engineer (QSE) positions to support QSCS projects for our end client. This is an excellent opportunity for experienced quality professionals with strong expertise in pFMEA, remediation activities, manufacturing quality, and FDA-regulated environments. The role requires strong expertise in FDA, ISO 13485, GMP compliance, and manufacturing quality systems. Key Responsibilities:Review and revise Process Failure Mode and Effects Analysis (pFMEA) documentation for medical device productsEvaluate and qualify product and process rework activities in compliance with approved protocols and regulatory requirementsReview, update, and maintain controlled documents including SOPs, work instructions, protocols, and batch recordsSupport risk assessments and impact evaluations related to historical deviations and nonconformancesEnsure all documentation maintains traceability, scientific justification, and regulatory complianceCollaborate with Engineering, Quality Assurance, and Manufacturing teams to gather technical inputs and resolve quality issuesParticipate in root cause investigations and support CAPA implementation activitiesMaintain detailed remediation records and ensure timely completion of assigned deliverables. Required Qualifications:Bachelor’s degree or higher in Mechanical Engineering, Biomedical Engineering, Materials Science, Quality Management, or related fieldMinimum 5 years of experience in Quality Engineering or Quality Management within the medical device or regulated manufacturing industryStrong knowledge of FDA regulations, ISO 13485, and GMP standardsExperience with DHR review processes and failure analysis methodologiesHands-on experience with quality tools such as FMEA, SPC, 8D, and other QC methodologiesStrong analytical and problem-solving skills with the ability to independently prepare analysis reportsProficiency in Excel, Minitab, or similar data analysis toolsExcellent verbal and written communication skills with the ability to work effectively in cross-functional teams. Preferred Qualifications:Experience with medical device registration, supplier quality management, or quality system audits.Familiarity with laboratory operations and measurement instruments.Continuous improvement mindset with the ability to proactively drive quality initiatives.