Sr Software Quality Engr

In this exciting role as a Senior Quality Engineer, you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices within component manufacturing. This includes activities related to development, test method validation, process validation, inspection improvements, and process/quality change initiatives and much more.

Responsibilities may include the following and other duties may be assigned as required:

• Provide Quality Engineering support for commercial medical device products.
• Develop, modify, apply and maintain quality standards and protocols for processing materials
• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
• Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
• Present technical data to groups within and outside the organization.
• Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.

What are the top 3 things you are looking for in a candidates experience:

• Experience with Software Validation for equipment used in production. Experience using SPC, CAPA, NCMR, PDP processes
• Working knowledge of Quality System Regulations such as (QSR 21 CFR 820), and ISO 13485:2016
• Excellent verbal and written communication, analytical, influencing and interpersonal skills

• Education Required: Bachelor’s Degree in Software Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality