Quality Systems Engineer

Company DescriptionSARACA is a global engineering R&D services company serving 25+ Fortune 500 customers across industries such as MedTech, Aerospace, Rail, Automotive, Semiconductor, and Defense. Specializing in innovative medical device design and development, SARACA is ISO 13485 certified with expertise in all classes of devices, including embedded software, UI/UX, mechanical systems, and product testing. The company has unique expertise in compliance with IEC 62304, EU MDR, and scientific writing for MedTech applications. With a global presence, a robust team of 400+ skilled professionals, and a dedication to solving complex business challenges, SARACA fosters a culture of innovation and learning. SARACA is an equal-opportunity employer focused on empowering customers to lead in their industries.Job SummarySaraca Solutions is seeking experienced Quality Systems Engineer to represent our team on-site at our client’s regulated Medical Device manufacturing facility. The professional will play a critical role in executing quality remediation activities to support compliance and process improvements. This opportunity involves working in a fast-paced, highly regulated environment, ensuring alignment with FDA, ISO 13485, and GMP standards.This position is expected to start as soon as possible, with a project duration determined by our client’s ongoing needs. Location: Acton, MA Key ResponsibilitiesReview and revise process failure mode and effect analysis (pFMEA) documentation for the medical device productsEvaluate and qualify product and process rework activities in accordance with approved protocols and applicable regulatory requirements.Review, revise, and update controlled documents such as SOPs, work instructions, protocols, and batch records.Support risk assessments and impact evaluations for historical deviations and nonconformances.Ensure all documentation reflects traceability, scientific justification, and alignment with regulatory expectations.Collaborate with cross-functional teams, including Engineering, QA, and Manufacturing, to obtain required technical inputs.Participate in root cause investigations and assist in the implementation of corrective and preventive actions (CAPAs).Maintain comprehensive records of remediation work and ensure timely completion of assigned deliverables. QualificationsBachelor’s degree or above in Mechanical Engineering, Materials Science, Biomedical Engineering, Quality Management, or related fields.Minimum 5 years of quality engineering or management experience in the medical device or related industry, with solid knowledge of FDA, ISO 13485 and GMP regulations.Proficient in DHR review processes and failure analysis methodologies, with strong problem-solving skills.Skilled in quality tools (FMEA, SPC, 8D, QC tools) and capable of independently preparing analysis reports.Familiar with common measurement instruments and laboratory operations.Strong communication and teamwork skills; able to work under pressure.Advanced data analysis skills; proficient in Excel, Minitab, or similar tools.Experience with medical device registration, quality system audits, or supplier management is a plus.Continuous improvement mindset and ability to proactively drive projects.Excellent English reading, writing, and speaking skills are mandatory. Ability to read and draft technical documents and communicate with global teams in English is required.