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Suttons Creek · 3 days ago

Quality Systems Consultant- Combination Devices

United States

Full-time

Hybrid

Senior Level, Lead/Staff

$150K/yr - $180K/yr

7+ years exp

Suttons Creek is a fully remote consultancy supporting the medical device, pharmaceutical, and biotechnology industries. They are looking for a Principal or Senior Quality Systems Engineer to lead complex combination product quality programs, ensuring alignment with industry standards and regulatory requirements while guiding programs from concept through market launch.

ConsultingHealth CarePharmaceuticalProduct DesignRisk ManagementTraining

Hiring Manager

Nina Provenzano

Responsibilities

Serve as technical lead or system quality engineering authority for drug delivery combination product programs

Guide architecture development, requirements management, system integration, and risk mitigation

Lead technical discussions with internal teams and pharmaceutical partners to ensure alignment of requirements and design intent

Develop and review quality systems/design control deliverables to document compliance with medical device development processes

Ensure compliance with ISO 13485, ISO 14971, 21CFR 820.30, and applicable combination product regulations

Act as Subject Matter Expert, reviewer, or approver for controlled documents within your technical domain

Prepare detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria

Establish and maintain project timelines, deliverables, and budgets ensuring successful program execution

Align program execution with industry standards, external regulatory requirements and site quality management systems

Apply regulatory and quality requirements to ensure patient safety and product performance

Qualification

Quality Systems EngineeringMedical Device ComplianceDesign ControlsRisk ManagementProject ManagementTechnical LeadershipTeam CoordinationTechnical DiscussionsCommunication SkillsProblem Solving

Required

BS in Engineering, Biology, Physics or related Scientific discipline

7-10+ years as Principal or Sr. Quality system engineer, technical lead, or equivalent experience in the development of combination products and/or medical devices

Thorough understanding of medical device processes: Design Controls (21 CFR 820.30), ISO13485, ISO14971

Technical management of programs in both direct or matrix reporting organizations, including coordinating and leading multiple team members through the execution of program deliverables

Experience with the total lifecycle management of quality systems including medical device programs, with preferred experience in the clinical and commercial development of drug delivery systems (combination products)

Direct experience developing design history file (DHF) documentation in quality management systems, including design plans, risk management, verification, validation, design transfer

Experience in leading technical discussions for internal and client teams as a technical subject matter expert on the development of drug delivery systems

Preferred

Pharmaceutical-related medical device experience on combination products and/or quality management systems preferred with combination products, such as Autoinjectors, Pre-filled syringe, or on-body delivery systems

Experience with project management

Master's degree in engineering, Biology, Physics or related Scientific discipline