Senior Quality Engineer

This is an exciting opportunity to join a global company in the medical devices industry. The Senior Design Quality Engineer (Hardware & Software) is a senior individual contributor within the company’s Global Quality & Compliance (GQ&C) organization. This position has the option to work onsite in Rochester, New York or San Diego, California.

Key Responsibilities

• 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.
• 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.
• 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.
• Represents Quality during regulatory inspections, notified body audits, and internal audits as a technical authority.
• 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.
• Partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle and contributes to harmonization, inspection readiness, and continuous improvement initiatives.

Qualifications

• 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.

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.

Pay Rate: $45-$65/hour