Quality Engineer 3

Job Title: Quality Engineer III
Location: Austin TX
Duration: 06 Months Contract/Temp with the possibility of extension
Shift Details: 1^st Shift (08:00 AM to 05:00 PM)

Job Requirements:
Ensure the design and development processes are followed and specific controls are in place and documented to ensure adequate quality at all product realization stages.
Ensure compliance with 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 21 CFR part 820 Directive 93/42/EEC Regulation (EU) 2017/745 ISO 13485 ISO 14971 and other applicable regulations and standards i.e. IEC 606011 IEC 62366 IEC 62304.
Collaborate with design and engineering teams that all product realization processes are applied and the product is compliant.
Review the design and development documentation for adequacy and ensure that they are consistent with the companywide global processes.
Supports evaluates and monitors that the required verification and validation processes are performed and documented.
Involved in the design and development phase from the 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 a 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 nonconformance 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 the 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 the investigation RCA Corrective Action Planning and Implementation activities
Lead and/or participate in process validation and risk management activities

Education and Experience:
B.S. degree (ME or EE preferred) and 58 years of related experience in the medical device industry OR M.S. Degree with 4 years of related experience
Preferred ASQ Certified Quality Engineer or Certified Reliability Engineer.