Supplier Qual Engineer II

The role is responsible for managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies. Primary duties focus on all Quality Management System (QMS) related matters, including supplier selection, processing supplier change requests, qualification, manufacturing, QMS development, and technical quality/service/cost improvements. Must Have APQP/FMEA APQP/PPAP Practitioner Develop control plans SCAPA Responsibilities Lead, support, review, and approve supplier change requests (SCR), Validation, TMV, PPAP, CAPA, QMS, etc. Work with new and existing clients/suppliers to develop, implement, and maintain technical quality assurance systems and activities, including Quality Plans, Control Plans, and FMEAs. Familiarity with medical industry requirements such as ISO 13485, 21 CFR 820 standards, etc. Represent the supplier quality engineering function to develop and execute the strategy to organize, direct, and report on all CM quality-related activities for contracted design and manufactured items. Lead PPAP qualifications with the client. Collaborate with clients to develop robust SCAPAs. Support the Quality team to develop and improve an effective Supplier Quality process that supports finished goods product quality globally. Develop, implement, and monitor client/supplier's development initiatives, including CM performance management, CM certification, process improvements, cost reduction, supplier forums, Six Sigma/Lean integration, audits, and selection activities. Collaborate on New Product Development (NPD) teams to evaluate and understand future client needs and their associated quality and development plans. Build and own the strategy for managing the client/suppliers for the business. Communicate with the business Quality lead on CM initiatives, updates, and issues. Ensure CM compliance with business Quality Systems and all relevant internal procedures and policies. Facilitate customer complaints for CM products and ensure adequate investigation and corrective actions are taken by the client. Manage Supplier Corrective Action Request program to ensure consistency in handling corrective actions by the client. Develop, communicate, and manage a strategy/plan for addressing finished goods client/suppliers capability deficiencies. Ensure proper approval and documentation practices are followed for any process, material, or tooling change (SCR – Supplier Change Request) at the client. Define and manage the process for growing effective "partnerships" with preferred clients to drive optimal performance. Lead by example: Setting a continuous-improvement driven mentality and solid quality culture for the organization. Maintain compliance to set Key Performance Indicators for the business. Manage and report on client/suppliers audit program in line with ISO and/or FDA 21 CFR part 820 regulations. Translate engineering, manufacturing, and quality requirements for CM products. Perform deviation investigations into quality issues arising from CM activities. Manage qualifications of changes and coordinate associated change control activities. Evaluate clients using the appropriate CM performance management processes and develop reports on CM quality performance for company management. Responsible for ensuring that effective up-to-date CM Quality Assurance documentation, procedures, and specifications are maintained. Participate in annual supplier forums and business reviews. Nice to Have 10 years of experience in the medical device industry, with a strong background in field corrective actions, CAPA, or product quality management. Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations. Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry. Strong project management skills, with the ability to manage multiple priorities and deadlines. Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions. Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders. Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability. Demonstrated track record of effectively influencing and negotiating with all levels of an organization and leading effective/successful change initiatives. Demonstrated knowledge and expertise in supply chain management and supplier development, stakeholder management, risk/issue management, and implementation planning. Knowledge of plant operations preferred. Design Control knowledge preferred. Knowledge of sterilization methods preferred. Thorough understanding of US and international regulatory and quality assurance requirements associated with the development and manufacture of medical devices or drug products. Electronics Qualification/Experience would be an advantage. Working knowledge of inspection and test techniques, quality assurance procedures, statistical analysis, product usage, and device regulations. Knowledge of Quality System Regulations (QSR) and ISO requirements. Ability to budget for future expenditures and manage departmental budget. Ability to prepare and execute effective presentations to others. ISO 13485:2003 Certified Lead Auditor. 6 Sigma and/or Lean experience preferred (trained or certified). Education Required Bachelor’s Degree in Engineering/Scientific/Electronic or technical field. Experience Required Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. Work Details 40 hours weekly, full-time on-site at 60 Middletown Ave, North Haven, CT 06473. #J-18808-Ljbffr