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Quality Assurance Specialist

Job Title
Quality Assurance Specialist
Job ID
Eden Prairie,  MN 55346
Other Location
Nortech Systems, Inc. (www.nortechsys.com) is a full-service electronics manufacturing services (EMS) provider of wire and cable assemblies, printed circuit board assemblies, and higher-level complete box build assemblies for a wide range of industries.  Markets served include global industrial equipment, aerospace/defense and medical applications.
Nortech is currently hiring for the following position:
Quality Assurance Specialist (Eden Prairie)
(All applicants must be US Citizen or US persons due to ITAR regulation)
This position is responsible for planning and conducting activities concerned with the quality management system (QMS) and the quality assurance of medical device processes, materials and products by performing the following duties.
Essential Duties and Responsibilities:
Working in conjunction with all departments, we will rely on you to perform the following:
  • Continually assesses the impact of medical device industry and business process changes to ensure continued regulatory compliance of the QMS.
  • Maintains a working knowledge of international and domestic government and medical industry quality assurance standards and guidelines, including 21 CFR 11, 21 CFR 801, 21 CFR 820, and ISO 13485.
  • Identifies quality problems and concerns, performs effective root cause analysis, and develops and implements appropriate corrective or preventive remedial action.
  • Plans, performs, and reports the findings of internal and supplier quality audits.
  • Serves as the primary contact for external quality audits from regulatory bodies and customers.
  • Evaluates and approves suppliers, and monitors supplier quality performance.
  • Plans and conducts the analysis, inspection, design, test, and/or integration to assure the quality of products, materials, and components; recommends appropriate product and process performance targets.
  • Performs quality reviews and approvals of design and manufacturing documentation for compliance with stated requirements, including company quality records.
  • Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
  • Documents data obtained during all quality assurance activities, consistent with company policies and procedures.
  • Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
  • Directs team members and technical and administrative workers engaged in quality assurance activities.
  • Proactively seeks and consistently embodies Nortech’s mission & core values; inspiring & demonstrating motivated behaviors of Respect, being Customer-Focused & Committed to Success, providing Great Communication & a Sense of Urgency, and being One Nortech where No One Does It Alone.
  • Supports Nortech’s corporative initiative for Continuous Improvement “FOCUS” by promoting the relentless pursuit of eliminating waste, participating in process improvement, and showing the courage to take action and advocate change.
  • Observes safety and security procedures, including maintaining confidentially, using equipment / materials properly, reporting potentially unsafe conditions, and acting upon appropriate actions.
  • Supports Nortech’s policies and procedures and conducts departmental and Company activities in accordance with these policies.
Minimum Qualifications
  • Bachelor’s degree (BS, BA) with 3+ years’ experience, or an Associate’s degree (AA) with 5+ years’ experience, in medical device quality.
  • Certified ISO 13485 auditor (preferred)
  • Certified quality or biomedical auditor (preferred)
Nortech Systems, Inc. offers its employees:
  • 401(k) program with Company match
  • Health, dental and vision insurance is available to all employees working 30+ hours per week
  • Life insurance
  • Paid Time Off (PTO) and paid holidays for full-time employees
  • Employee Assistance Program (EAP)
  • And much more!
Visit our Career page at nortechsys.com for more information on our employee benefits.
Equal Opportunity Employer and Substance Free Workplace
Certain positions at Nortech require access to information, or technology that is subject to the International Traffic in Arms Regulations (ITAR) and other US government security regulations. These laws do not permit access rights to non-US citizens, or to other unauthorized individuals. Therefore, presently, all applicants must be US Citizens, or US Permanent Residents (“green card holders”), and/or otherwise comply with ITAR requirements for access rights, to be considered for a position.