Quality Engineer

Job 2706 - Quality Engineer - Contract located near Minneapolis, MinnesotaMedical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.OnsitePurpose Statement Develops, establishes and maintains quality engineering methodologies, systems and practices which meet our client's 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 ResponsibilitiesSupports 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 GuidelinesKnowledge 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 SolvingDevelops 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 OrganizationPlans and organizes non-routine tasks w/approval.Initiates or maintains work schedule and priorities.Plans and organizes project assignments and maintains project schedules.Discretion/LatitudeSupervisionDecision MakingWorks 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 ManagementCultivates 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 RequirementsIn 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.RequirementsAt least 3 years' experience in the med device industryFunctional understanding of design controls including experience developing, updating and maintaining product Design History Files and Design Input / Output documentations, Product Specification Component Specifications and PrintsFunctional understanding of risk controls including experience with updating and maintaining risk management documentation: DFMEA and Hazard AnalysisMEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.Sponsorship is not available for this positionCheck us out at www.medicalengineeringconsultants.comAAP/EEO DFWPReasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Other DutiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.