Senior Design Quality Engineer
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.1
Reclaim your time by letting our AI handle the grunt work of job searching.
We continuously scan millions of openings to find your top matches.
Overview
Remote
On-site
Compensation
$45-$65/hour
Job Description
(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 NYJob Duration: 12 MonthsPosition Title: Sr. Quality Partner, Design Quality – HW & SWDescription:
- 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.
- 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 scientific capability.
- Communicate Quality-related risks, recommendations, and progress to project teams, cross-functional partners, and Quality leadership.
- Perform other work-related duties as assigned.
- Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required.
- 5+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries
- Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
- Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.
- Excellent collaboration, influence, and communication skills across functional and organizational boundaries.
- Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement.
- Commitment to scientific integrity, compliance excellence, and continuous improvement.
- Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline.
- Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools.
- Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise.
- Experience supporting or leading Health Authority or Notified Body inspections.
The Work:
- Environment Typical office or laboratory environment. May involve virtual collaboration across multiple global sites.
The Physical:
- Demands No strenuous physical activity required. May include occasional travel for site visits, leadership meetings, or regulatory support.
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
FAQs About Senior Design Quality Engineer Jobs at HonorVet Technologies
What is the work location for this position at HonorVet Technologies?
This job at HonorVet Technologies is located in Rochester, NY, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at HonorVet Technologies?
Candidates can expect a pay range of $45–$65 per hour for this role.
What employment applies to this position at HonorVet Technologies?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at HonorVet Technologies?
You can apply for this role at HonorVet Technologies either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.