Design Quality Engineer Medical Device

Title: Senior Design Quality Engineer
Location: Rochester NY or San Diego CA
Duration: 12 Months

The Position
The Senior Design Quality Engineer (Hardware & Software) is a senior individual contributor within QuidelOrthos 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 supporbusiness 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 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.

The Key Stakeholders/Internal Customers

• Operations
• R&D
• Commercial
• Regulatory Affairs
• Quality & Compliance teams globally and regionally

External Customers

• Regulatory agencies
• Notified bodies

Required Skills

• Bachelors 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.

Preferred Skills

• 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.