POSITION

Quality Engineer II (Design Quality Engineer III)

FULLTIME

12-Month Assignment

LOCATION

Maple Grove, MN

SCHEDULE

40/HRS

PAY RANGE

$55/HR (Exact compensation may vary based on skills, experience, and location. Base pay information is based on market location.)

JOB DESCRIPTION

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. Key Responsibilities 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. Job Scope and Leveling Guidelines Knowledge An experienced professional with functional understanding and wide application of principle, theories, and concepts in the field. Applies an understanding of area of specialization to analyze and remediate identified design control vulnerabilities. General knowledge of other related disciplines, business unit function and cross group dependencies/relationships. Problem Solving Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit. Planning and Organization Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules. Discretion/Latitude; Supervision Received; Decision Making Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives. Business Relationships and Project Management Cultivates a wide range of business relationships to facilitate completion of assignments. Participates in determining goals and objectives for projects. May lead projects within the Impact Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources. Liaison Engages with internal company contacts. Represents organization on specific projects. Uses diplomacy and tact in interactions and problem solving. May escalate serious issues to manager. Quality System Requirements In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Management Requirements Requirements At least 3 years experience in the med device industry. MEE experience. Functional understanding of design controls including experience developing, updating, and maintaining product Design History Files and Design Input / Output documentations (Product Specification, Component Specifications, and Prints) Functional understanding of risk controls including experience with updating and maintaining risk management documentation: DFMEA and Hazard Analysis

WORKING CONDITIONS

May on occasion be exposed to loud sounds and distracting noise levels, such as from office equipment. The ability to lift up to 30lbs Use of computers and technology Here at Canon Recruiting, People are our priority, and we are committed to Include Diversity in every segment of who we are. It is only through our Diversity, we are made a stronger organization, and increase our ability to provide top tier candidates that our clients have come to know Canon for. We have an inclusive environment all employees are celebrated for their unique differences. The different perspectives and experiences of our workforce give us the competitive advantage that is essential for success in an ever-changing market. By promoting inclusion with the same enthusiasm, we devote to quality and competency, and using the experience from a diverse assortment of backgrounds and experiences, Canon is able to improve the services and value we deliver to clients, employees, and customers. At Canon, Diversification and Inclusiveness are much more than a corporate ambition; they are a critical component in our daily corporate life. Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. The pay range for this position is listed above. Base pay information is based on market location. We will consider for employment qualified applicants with arrest and conviction records. Our range of benefits may include health care and 401(k) savings plans. 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