Design Quality Engineer III

POSITION:
Quality Engineer II (Design Quality Engineer III)

FULLTIME: 12-Month Assignment
SCHEDULE: 40/hr
LOCATION: Maple Grove, MN
Salary Range: $55/hr (Exact compensation may vary based on skills, experience, and location. Base pay information is based on market location.)

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, execution and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within the product sustaining group, including Design History File (DHF) remediation and design controls activities to ensure objective evidence is complete, consistent, and inspection-ready.

• Supports Design History File (DHF) remediation initiatives by assisting with gap assessments, evidence collection, and documentation updates to close design control deficiencies for sustaining products.
• Supports remediation planning by helping define scope, assumptions, and acceptance criteria for use of legacy evidence; identifies when additional documentation, review, or testing may be needed and escalates to the remediation lead.
• Assists with creating and/or updating DHF content as applicable (e.g., design inputs/outputs, design review documentation, verification/validation evidence mapping, and traceability matrices) in accordance with internal procedures and regulatory requirements.
• Leads analysis and proactive upkeep of product risk management tools such as Hazard Analysis and DFMEA, including alignment of risk controls to remediated DHF documentation (inputs/outputs, verification, validation, labeling, and post‑market information as applicable).
• Supports end‑to‑end traceability by helping reconcile relationships between design inputs, design outputs, risk controls, verification, and validation; documents discrepancies and supports closure of traceability gaps.
• Coordinates with cross‑functional partners (e.g., R&D, Manufacturing, RA, Document Control) to route DHF remediation updates for review/approval and ensure documentation is completed, version‑controlled, and available within required quality systems.
• Supports inspection/audit readiness for remediated DHFs by helping organize objective evidence, preparing summaries of remediation decisions/rationale, and assisting in responses to auditor questions under the direction of the remediation lead.
• Acts as an effective team member in supporting quality disciplines, decisions, and practices; may own assigned remediation tasks/deliverables and drive them to closure in alignment with the remediation plan.
• Applies sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including documentation and compliance gaps identified during DHF remediation.
• Supports remediation execution by maintaining assigned trackers/records (e.g., gap lists, action items, evidence inventories) and proactively communicating status, risks, and roadblocks to the remediation lead and functional stakeholders.

• Knowledge
  :
  Experienced professional with functional understanding and wide application of principles, theories, and concepts in the field. Applies an understanding of area of specialization to analyze and remediate identified design control vulnerabilities. General knowledge of related disciplines, business unit function and cross‑group dependencies.
• Problem Solving
  :
  Develops solutions to a variety of complex problems where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within defined practices and policies in selecting methods and techniques. Broad knowledge of alternatives and their impact on the business unit.
• Planning & Organization
  :
  Plans and organizes non‑routine tasks with approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.
• Discretion/Latitude,…