Senior Design Quality Engineer

Senior Design Quality Engineer

Basic Job Information Honor Vet Technologies (SDVOSB) provides specialized and scalable staffing solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs, research laboratories, and life sciences organizations across the United States. With strong delivery capabilities and rapid turnaround times, we support contract, direct hire, project-based, and consulting staffing needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control, medical affairs, manufacturing, validation, and scientific operations.

Our dedicated recruitment team focuses on delivering qualified life sciences and pharmaceutical professionals efficiently while ensuring quality, compliance, and client satisfaction.

Job Title:
Senior Design Quality Engineer

Job Location:

Rochester NY Job Duration: 12 Months

Position Title:

Sr. Quality Partner, Design Quality – HW & SW

Description:

• The Position The Senior Design Quality Engineer (Hardware & Software) is a senior individual contributor within client's Global Quality & Compliance (GQ&C) organization.
• This role provides technical support in the execution, oversight, and continuous improvement of Quality systems, processes, and programs that enable compliant product development and support business agility, innovation, and growth.
• The Senior Engineer provides subject-matter expertise across the product design lifecycle, with substantial responsibility for Design Controls and Risk Management for hardware, software, and integrated IVD systems.
• This role ensures that user needs, requirements, and claims are scientifically justified and translated into robust, testable criteria that support safe and effective product performance.
• As a key Quality partner for cross-functional development teams, this role leads Quality engineering activities related to design changes, validation strategies, and claim verification approaches.
• The Senior Engineer also represents Quality during regulatory inspections, notified body audits, and internal audits as a technical authority.
• This role ensures alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and related standards) and demonstrates strong technical depth, systems thinking, and the ability to navigate complex, fast-paced environments while promoting a proactive and collaborative Quality culture.
• The Senior Design Quality Engineer partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle and contributes to harmonization, inspection readiness, and continuous improvement initiatives.
• The role also supports organizational capability by mentoring others, driving technical problem-solving, and contributing to a culture of engagement, scientific excellence, and high performance.
• By integrating technical expertise, data-driven insights, and strong Quality discipline, the Senior Engineer ensures that Quality systems and processes deliver sustainable business and compliance outcomes.

Key Responsibilities:

• Support complex Quality engineering activities that support business and compliance priorities, ensuring timely delivery and high technical rigor.
• Apply technical, regulatory, and Quality systems knowledge to ensure compliance with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards.
• Support the harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen consistency and efficiency.
• Collaborate closely with R&D, Regulatory Affairs, Manufacturing, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.
• Drive continuous improvement initiatives, identifying opportunities for simplification, process optimization, and digital enablement within the Quality Management System (QMS).
• Support a high level of inspection readiness and serve as a Quality representative during regulatory agency inspections, notified body audits, and internal audits.
• Provide coaching and technical guidance to peers, junior engineers, and project teams to strengthen organizational Quality and…