Quality Engineer

3 weeks ago

Austin, United States The Judge Group Full time

Our client is currently seeking a Quality Engineer - Design for a 6 month + contract.
Designs, implements and maintains quality assurance protocols and methods throughout the product design process from concept to design transfer for commercialization. Provides input to planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Supports activities to develop methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, MDR). The QA Engineer works within an existing Quality Engineering team to execute on or accomplish the following activities: • Ensure the design and development processes are followed, specific controls are in place and documented to ensure adequate quality at all product realization stages. • Ensure compliance to current regulatory procedures and changes throughout the complete product life cycle. • Support the RA/QA team in internal and external audits. • Collaborate with other teams and stakeholders. • Main Responsibility: Ensures compliance requirements according to 21CFR part 820, Directive 93/42/EEC, Regulation (EU) 2017/745, ISO 13485, ISO 14971, and other applicable regulations and standards, i.e. IEC 60601-1, IEC 62366, IEC 62304. • Collaborate with design and engineering teams that all product realization processes are applied, and the product is compliant. • Review of the design and development documentation for adequacy and ensures that they are consistent with the company wide, global processes. • Supports, evaluates, and monitors that the required verification and validation processes are performed and documented. • Involved in design and development phase from beginning to support risk management and to implement the required controls at the final production stage. • Define and ensure that statistical data is collected and analyzed. • Supports and evaluates engineering teams with the root cause analysis and corrective actions implementation. • Assist in New Product Introduction/Design Transfer activities to characterize manufacturing processes for parts/components in development to ensure smooth transition from R&D to manufacturing, including participation and leadership of the development of equipment and process validation requirements (FMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques • Generate internal quality documentation such as quality plans, SOPs and inspection procedures. Ensure QA, FDA and ISO compliance in all areas of responsibilities • Review and approve product and Quality System changes with Engineering and Manufacturing to ensure Quality System compliance • Provide engineering support to manufacturing and resolve issues impacting production fulfillment specifically nonconforming material • Participate in Quality Review Boards, including the identification of non-conformance trends and development of technical investigation plans. Investigate and analyze customer/internal complaints as needed • Provide all planning necessary to ensure effective product acceptance based on DMR • Assist in implementation of QA plans, process controls, and CAPA systems designed to meet internal and external requirements • Assist in the evaluation of manufacturing processes by designing and conducting research programs • Assist in investigation, RCA, Corrective Action Planning and Implementation activities • Lead and/or participate in process validation and risk management activitiesEducation and Experience: • B.S. degree (ME or EE preferred) and 5-8 years of related experience in medical device industry OR M. S. Degree with 4+ years of related experience • Preferred - ASQ Certified Quality Engineer or Certified Reliability Engineer.

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