- Over 10+ years of diversified experience as Development Design /Supply Quality Engineer. Perform Development Quality, and tactical supplier quality duties, both in product R&D and manufacturing meeting Compliance Standards.
- Professional experience in Process Improvements, design controls, compliance Verification and validation plans, testing, and generation of test reports. Interface with development engineers, manufacturing engineers, product managers and participate in design reviews.
- Ensure compliance with current international regulations pertaining to FDA QSRs ISO 9001, ISO 14971 and ISO13485.
- Work with cross - functional teams to improve processes and procedures, and implement changes as driven by internal and external factors. Monitor and measure performance of suppliers and report to management as required.
- Participate in Supplier Quality harmonization activities as new sites/businesses are acquired.
- Bench-mark and network within TE and outside the company to develop new ideas, and drive these to execution.
Sr. R&D Design Quality Engineer
- Evaluate procedures and processes within the quality system to identify areas for improvement, support international sites in China, the US, and Mexico Recommend solutions to identified problems. Engaged in sustaining engineering projects to plan, execute, verify and document commercialized product remediation. Carry out audits to ensure compliance company requirements Participate in Supplier Quality harmonization activities as new sites/businesses are acquired
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality engineering tests; and analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. Support areas of design control, process controls, verification /validation, production control, product evaluation and reliability as they apply to product or process quality. Supplier Onsite and remote support, training, consulting and engineering assistance to manufacturing sites. Developing training, implementing and providing ongoing support for design team quality system elements.
Sr. R&D Design Quality Engineer
- Research; train North America personnel in science and application of Electrostatic
- Discharge (ESD) awareness. Assist suppliers during process /product improvement.
- Work with team to facilitate return product. Root cause analysis, Quality Improvements
- Assure Quality Systems are in full compliance, ISO-9001, EN60335, IEC60730 and international quality
Sr. Principal Hardware Design / Supply Quality Engineer
- Provides global Supplier Quality engineering management support to the Business and its
- Suppliers of direct materials and services. Provides support to the development of Performance
- Management and Change Management Programs utilizing the best practice models for Supplier
- Quality while meeting all regulatory requirements in the respective markets and regions. Key is supporting the quality planning process to drive continuous improvement and changes of
- Confidential supplier quality process to ensure ongoing effectiveness and efficiency
- New product development and sustaining products Establish & implement supplier quality procedures in adherence with global policies & guidelines, ensuring efficient continuous monitoring systems are in place support of quality assurance programs, policies, processes, procedures
- Controls in Compliance, US and global requirements
- Act as a subject matter expert involving quality system elements including hardware work products to ensure compliance.
- System-level project / programs work products (e.g., plans, requirements, specifications, tests test results, traceability, risk management documents, reports)
- Facilitate and coordinate multiple cross-functional group
- Risk management program, change impact assessment program and product process risk.
Senior R&D Design Quality Engineer
- Identifying potential risk suppliers from the location / factory SQM point of view and introduction of adequate measures and ensuring that potential risks in the material's manufacturing process are reduced/avoided on a lasting basis
- Controlling corrective measures including specific measures. Quality Engineering technical leadership, Lead Project Teams Root cause analysis, continuously improve quality, cost and time factor, Reliability and improvements. Support Failure and Complaint Investigations.
- Conducts supplier quality system and product audits as needed.
Senior R&D Electrical Quality Engineer
- Product development quality design, Design reviews, Design Control,
- Product Validation / Verification Quality agreement, supply quality, Supplier training,
- PCBA's process improvement, Master Validation Plan, Validation Plan
- Manufacturing MIP's, SOP's, Manufacturing Operation Process Plan, Incoming Inspection Methods, Complaint Investigation, Risk management (DFMEA). Feasibility study to Product released, directly supervises 5 employees in the QA department
- Corrective actions related to audit findings, nonconforming product
Senior Quality Engineer
- Investigate and Process the Complaints implements, and maintains the quality policy,
- Ensures compliance to division, site & department level policies and procedures.
- Review test data and relate to impact on FileMaker documents and claims Review and interpret customer complaints Risk Evaluation.Tracking and Trending Analysis (CATS)
Senior Development Quality Engineer
- Develop software validation test plans for class II device & I.
- Support the R&D team in the development of new Diabetes devices
- Drive Confidential Diabetes Meter Quality from concept to production
- Quality plans, Risk management and assessment, failure modes and effects analysis,
- Statistical Analysis, Implementation, integration. Qualifying diabetes meter critical suppliers
- Lead the effort for establishing systems and lead audits for ISO 13485 certification.
- Responsible for product release, commercial, device and investigational materials.
- Assists in product design documentation reviews for safety, consistency, traceability, an compliance to regulations such as the FDA QSR design control requirements 21 CFR Par
- 820.30. And ISO 14971. Review SWQA work team and liaison between development and quality department. Design verification/validation test protocols for embedded systems. Review agile documentation for accuracy, clarity, and consistency.