Job Description
Job Description
Position Overview:
- In this exciting role as a Software Quality Engineer at the Company Energy and Component Center 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.
Technical Skills
Must Have:
- Computer and software validation
- Change control of Medical Devices
- Investigation and root cause analysis skills
- Technical writing knowledge
- Organization and Communication skills
- Process Validation and Computer software validation knowledge
Nice To Have:
- DRM Greenbelt Certification
Top 3 Required Skill Sets:
- 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
Position Responsibilities:
- Provide Software Quality Engineering support for new product commercial medical device component manufacturing lines.
- 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 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.
Does this person need to be on site? If so, full time or part time? Yes, 4 days per week