Job Description
Job DescriptionJob Title: Software Quality Engineer
Job Description
This role provides comprehensive software and manufacturing quality support for commercial medical device component manufacturing. You will lead and support software validation, process validation, test method validation, inspection improvements, and process and quality change initiatives for production equipment and software systems. The position focuses on ensuring that software and processes used in production meet applicable quality system regulations, industry standards, and internal requirements, while enabling reliable, compliant, and efficient manufacturing operations.
Responsibilities
- Provide Software Quality Engineering support for new and existing commercial medical device component manufacturing lines, with a focus on software and computer systems used in production.
- Develop, modify, apply, and maintain quality standards and protocols for processing materials and for software systems, including operating methods, processes, and procedures.
- Conduct evaluations of software systems activities, including requirements, design, development, documentation, integration, test, verification, and validation, to ensure compliance with quality and regulatory requirements.
- Ensure that corrective and preventive actions meet acceptable reliability standards and that all supporting documentation is complete, accurate, and compliant with applicable requirements.
- Collaborate closely with engineering and manufacturing functions to ensure appropriate quality standards, software controls, and validation requirements are defined, implemented, and maintained.
- Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment, including software-driven systems.
- Design or specify inspection and testing mechanisms and equipment, conduct quality assurance tests, and perform statistical analysis to assess the cost of nonconformance and determine responsibility for products or materials that do not meet required standards and specifications.
- Apply knowledge of design control principles, statistics, process and systems validation, and quality engineering techniques to influence projects and manufacturing processes positively.
- Ensure that changes to products, processes, and software are developed, validated, and implemented in accordance with applicable industry standards, regulatory requirements, and customer requirements.
- Utilize quality tools such as risk analysis, FMEA, statistical techniques including Six Sigma and design of experiments (DOE), root cause analysis, and drawing review and correction to support investigations and continuous improvement.
- Develop and maintain standards for software systems quality, including defining appropriate measures and criteria to ensure product and software quality throughout the lifecycle.
- Develop overall operating criteria to ensure implementation of the software quality program according to project, process, and contract requirements and objectives.
- Ensure that project and process control documentation, including validation protocols, reports, and procedures, are compliant with applicable requirements, objectives, and contracts.
- Review software systems design, change specifications, and plans against contractual and process requirements, including applicable specifications, materials, tools, techniques, and methodologies.
- Provide or direct verification and validation of software system requirements, including ensuring traceability and testability from requirements through testing.
- Lead or support investigations using SPC, CAPA, NCMR, and PDP processes, performing structured root cause analysis and driving effective corrective and preventive actions.
- Present technical data, analyses, and recommendations to groups within the organization, clearly communicating findings, risks, and proposed actions.
- Contribute to cross-functional projects from design through implementation, setting objectives for your own work area and helping ensure completion of project milestones.
- Provide guidance and assistance to entry-level professionals or support staff as needed, sharing best practices in software quality and validation.
- Recommend enhancements to systems, processes, and documentation to improve the effectiveness and robustness of the quality management system.
Essential Skills
- Experience with software validation for equipment used in production environments, particularly within a regulated industry.
- Experience using Statistical Process Control (SPC), Corrective and Preventive Action (CAPA), Nonconforming Material Reporting (NCMR), and Product Development Process (PDP) methodologies.
- Working knowledge of Quality System Regulations such as QSR 21 CFR 820 and ISO 13485:2016 or similar quality management system standards.
- Strong computer and software validation skills, including planning, executing, and documenting validation activities for production-related software and systems.
- Experience with change control for medical devices, including software and process changes within a regulated quality system.
- Demonstrated investigation and root cause analysis skills, including use of structured problem-solving tools.
- Technical writing skills with the ability to create clear, concise, and compliant documentation such as protocols, reports, procedures, and work instructions.
- Strong organizational and communication skills, with the ability to manage multiple tasks and communicate effectively with cross-functional teams.
- Knowledge of process validation and computer software validation principles and practices.
- Practical knowledge and demonstrated competence in software quality engineering, typically obtained through advanced education and relevant work experience.
- Requires a university degree (bachelor’s degree) and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.
- Excellent verbal and written communication skills, including the ability to influence and work effectively with diverse stakeholders.
- Strong analytical and interpersonal skills to interpret data, assess risks, and collaborate across functions.
Additional Skills & Qualifications
- DRM (Design for Reliability and Manufacturability) Greenbelt Certification or equivalent training in design and reliability methodologies.
- Experience applying design control principles in a medical device or similarly regulated environment.
- Familiarity with risk analysis tools such as FMEA for both product and process risk assessment.
- Experience with statistical techniques including Six Sigma methods and design of experiments (DOE).
- Experience reviewing and correcting engineering drawings and technical specifications.
- Ability to interpret and apply regulatory and standards requirements to software and manufacturing processes.
- Experience presenting technical information to internal stakeholders and gaining support for quality-related decisions.
- Ability to work independently with general supervision on moderately complex projects and assignments.
- Experience contributing to cross-functional projects and supporting project milestones.
- Capability to provide guidance and mentoring to entry-level professionals or support staff in quality or engineering functions.
Work Environment
This position is based at a manufacturing and engineering facility in Brooklyn Center, MN, with an expectation to be on site approximately four days per week while working a standard 40-hour workweek. You will work closely with engineering, manufacturing, and quality teams in a production environment that supports commercial medical device component manufacturing. The role involves regular interaction with production equipment, software systems, and quality tools such as SPC, CAPA, NCMR, and PDP processes, as well as statistical analysis and validation tools. The environment emphasizes adherence to quality system regulations and industry standards, structured documentation, and cross-functional collaboration. Work is primarily performed in an office and laboratory or production setting, using computers and standard engineering and quality software tools, with periodic presence on the manufacturing floor to support inspections, validations, and process improvements.
Job Type & Location
This is a Permanent position based out of Golden Valley, MN.
Pay and Benefits
The pay range for this position is $30.00 - $55.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Golden Valley,MN.
Application Deadline
This position is anticipated to close on Jul 23, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.