Website Artech LLC
Artech LLC
Company : Artech LLC
Job Title: Sr Software Quality Engineer
Job ID: 18711
Location: Brooklyn Center Minnesota 55430
Duration: 12 months
Payrate: $50.00-55.76/hr
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
In this exciting role as a Senior Quality Engineer at the Client Energy and Component Center (MECC) 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:
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.
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
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours
Work Location: Brooklyn Center, MN
Do they need to be local to any MDT office and if so where? Local to the MECC Facility
Does this person need to be on site? If so, full time or part time? Yes, 3 days per week
Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. Defines appropriate measures to ensure product quality. Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. Reviews software systems design, change specifications, and plans against contractual and/or process requirements. Reviews include applicable specifications, materials, tools, techniques, and methodologies. Provides or directs verification and validation of software system requirements, traceability, and testability.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others’ work product .
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Thank You
Ashwini Nair