Quality Engineer

Job 2706 - Quality Engineer - Contract

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to improve efficiency and productivity by providing resources, knowledge, and expertise to augment their work. Our vision is to align client needs with the best available resources, proactively address issues, and develop sustainable solutions that validate processes, ensure compliance, and close gaps between current and FDA‑expected stages.

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.

Develops, establishes, and maintains quality engineering methodologies, systems, and practices that meet client customer and regulatory requirements. Serves as a quality representative to enhance awareness, visibility, execution, and communication on quality initiatives across departmental, functional, site, divisional, and corporate levels. 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 assessing gaps, collecting evidence, and updating documentation to close design control deficiencies for sustaining products.
• Assists remediation planning by defining scope, assumptions, and acceptance criteria; identifies when additional documentation review or testing is needed and escalates to the remediation lead.
• Creates and/or updates DHF content (design inputs/outputs, design review, verification/validation evidence, mapping and traceability matrices) in accordance with internal procedures and regulatory requirements.
• Leads analysis and proactive maintenance of product risk management tools such as Hazard Analysis and DFMEA, aligning risk controls to remediated DHF documentation.
• Supports end‑to‑end traceability by reconciling relationships among design inputs, outputs, risk controls, verification, and validation documents, and by closing traceability gaps.
• Coordinates with cross‑functional partners (R&D, Manufacturing, RA, Document Control) to route DHF remediation updates for review/approval, ensuring documents are version‑controlled and available in required quality systems.
• Assists with inspection/audit readiness for remediated DHFs by organizing objective evidence, preparing remediation summaries, and responding to auditor questions under the remediation lead’s direction.
• Acts as an effective team member to support quality disciplines, owns assigned remediation tasks/deliverables, and drives them to closure in alignment with the remediation plan.
• Applies systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues, including documentation and compliance gaps during DHF remediation.
• Maintains assigned trackers/records (gap lists, action items, evidence inventories) and proactively communicates status, risks, and roadblocks to the remediation lead and stakeholders.

• Experienced professional with functional understanding of principles, theories, and concepts in the field.
• Applies understanding of specialization to analyze and remediate identified design control vulnerabilities.
• General knowledge of related disciplines, business unit functions, and cross‑group dependencies and relationships.

• Develops solutions to complex problems of diverse scope, requiring data analysis and evaluation of identifiable factors.
• Exercises authority and judgment within defined practices and policies to select methods that achieve solutions.
• Has broad knowledge of alternatives and their impact on the business unit.

• Plans and organizes non‑routine tasks with approval.
• Initiates or maintains work schedules and priorities.
• Plans and organizes project assignments, maintaining project schedules.

• Works under general direction regarding project and assignment progress.
• Independently…