Validation Quality Engineer

Company DescriptionSARACA is a global engineering R&D services company serving over 25 Fortune 500 companies across industries such as MedTech, Aerospace, Automotive, and Defense. Renowned for its expertise in medical device design and development, SARACA is ISO 13485 certified and specializes in areas like embedded software, UI/UX, mechanical systems, and product testing. With a team of 400+ skilled engineers and consultants, we excel in solving complex business challenges around the world. As an equal-opportunity employer, SARACA fosters a culture of innovation, continuous learning, and excellence, helping clients accelerate business growth and achieve industry leadership.Job Title: Senior Quality Engineer Location: Devens, MA, USA (Onsite) Experience: 5+ years Industry: Industrial Machinery Manufacturing. Key Responsibilities:Lead and manage sterility control and compliance programs Develop and maintain Quality Management System (QMS) processes, procedures, and documentation Provide quality support for NPI projects and change management activities Ensure effective Verification & Validation (V&V) of products and processes Drive investigation of non-conformities and quality events using eQMS Lead Corrective and Preventive Actions (CAPA) using root cause analysis tools (5 Whys, Fishbone, FMEA) Ensure risk assessment and impact analysis for product and process changes Collaborate with cross-functional teams to implement quality improvements Support and maintain validation protocols and documentation Conduct internal audits and generate audit reports Provide training, coaching, and guidance on quality systems and tools Promote a culture of quality, continuous improvement, and risk-based thinking Required Qualifications & Skills:Bachelor’s degree in Engineering or a Scientific discipline Minimum 5+ years of experience in Quality Assurance within a regulated industry Strong knowledge of ISO 13485, ISO 9001, and ISO 14644-1 standards Experience in product and process validation methodologies Hands-on experience with CAPA, root cause analysis, and quality investigations Proficiency in internal audits (Lead Auditor certification preferred) Strong understanding of the design and development lifecycle Experience supporting NPI and change management processes Excellent communication and stakeholder management skills Proven ability to drive continuous improvement and lean methodologies Additional Requirements:Ability to host/co-host ISO and customer audits Willingness to travel up to 30% Strong organizational, planning, and problem-solving skills Ability to work effectively in dynamic and cross-functional environments