Sr Software Quality Engr - Exempt

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

• Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.
• Conduct evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification, and validation.
• Define appropriate measures to ensure product quality.
• Develop overall operating criteria to ensure implementation of the software quality program according to project, process, and contract requirements and objectives.
• Ensure that projects and process control documentation are compliant with requirements, objectives, and/or contracts.
• Review software systems design, change specifications, and plans against contractual and/or process requirements.
• Provide or direct 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 direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while 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 in-depth 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 objectives, 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.

Additional Responsibilities

• 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; conduct quality assurance tests; and perform 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 cause analysis, reading and correcting drawings.

Top 3 Candidate Experience Requirements

• 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.

Skills

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.

Work Details

• Work Location: Brooklyn Center, MN
• Local to the MECC Facility
• On-site: Yes, 3 days per week
• Work Hours: 40 hours per week