Senior Design Quality Engineer

The Senior Design Quality Engineer is responsible for supporting New Product Introduction (NPI) programs in bringing the first complete, Next-Generation Protein Sequencing™ technology to market by providing input to the development teams and authoring or approving Design Controls deliverables. This position is also responsible for providing support and guidance for post market product sustaining activities, such as design changes and CAPAs. The successful candidate will play a critical role in ensuring the quality, reliability, and regulatory compliance of our products throughout the design and development lifecycle.

As part of our team, your core responsibilities will be:

• Actively represent Quality Assurance function on product/process development teams, ensure compliance to design control process.
• Develop and implement quality plans for new product development projects, ensuring alignment with regulatory requirements, industry standards, and company policies.
• Lead design control activities, including design inputs/outputs, risk management, verification and validation, design reviews, and design transfer, in accordance with ISO 13485, FDA QSR, and other applicable regulations.
• Lead the product development team through the risk analysis process including product hazard analysis, dFMEA, pFMEA, risk benefit analysis, and risk management planning and reporting supporting compliance with ISO 14971 throughout the product life cycle.
• Collaborate with suppliers to ensure the quality of components and materials used in product design, including supplier audits, qualifications, and ongoing monitoring.
• Manage design changes through formal change control processes, assessing impact on product quality, safety, and regulatory compliance.
• Provide guidance to Manufacturing regarding quality and cGMP issues to ensure compliance with regulated standards.
• Participate in development, review and approval of product requirements, product specifications, test protocols and reports. Review new and modified product design for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Develop, establish, and implement quality plans, validation and inspection plans.
• Conduct evaluations, tests, verifications, validations and make decisions to maintain compliance to Quality Management System, applicable regulations and standards.
• Interface with corporate partners regarding quality issues, audits, and special projects. Coordinate, review, and manage non-conformances and CAPAs. Communicate with suppliers and other functions internally and externally to investigate and troubleshoot issues. Create and review SCARs.
• Conduct product investigations, root cause analysis, and implementation of corrections and preventative actions.
• Create SOPs and Templates as needed to support Quality Management System

Qualifications

Baseline skills/experiences/attributes:

• Minimum eight years of experience in a Quality Assurance Specialist or Quality Engineer role at FDA regulated or ISO 13484 certified industry at both small and large companies. While the ideal candidate would have some exposure to life sciences, sequencing, diagnostics, and or medical devices.
• Bachelor's degree in chemistry, biochemistry, biology, engineering, or related discipline
• Experience assisting with investigations, root cause analysis, and reports.
• Ability to handle and resolve conflicts and work under schedule/milestone pressures
• Experience in instrumentation and software product development is a plus
• Experience working with CDMO and CMOs
• Effective written and verbal communication skills.
• Attention to detail, good organizational skills and team-oriented
• Relevant certifications (e.g., ASQ CQE, CRE) are a plus.

The estimated base salary range for this role based in the United States of America is: $120,000 - $135,000. Compensation decisions are dependent on several factors including, but not limited to, level of the position, an individual's skills, knowledge and abilities, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all full-time employees are eligible for our discretionary bonus program and equity as part of the compensation package.

For this role, we provide visa assistance for qualified candidates.

Quantum-Si does not accept agency resumes.

Quantum-Si is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.