Lead the design, implementation, maintenance, and continuous improvement of the site Quality Management System (QMS) to ensure compliance with applicable regulations and corporate quality standards.
Responsibilities
Own and continuously improve the QMS (policies, SOPs, work instructions, records) to align with cGxP expectations and corporate requirements.
Lead CAPA, nonconformance, deviation, change control, complaint handling, and recall readiness processes; ensure timely investigation, root-cause analysis, and effective remediation.
Develop and maintain a risk-based approach to quality (FMEA, QRM) and integrate risk management into product and process decisions.
Oversee internal and supplier audit programs; plan, coordinate, and lead internal and external audits and ensure timely closure of findings.
Support supplier qualification and ongoing supplier quality oversight, including audits, performance monitoring, and corrective actions.
Requirements
Bachelor’s degree in Life Sciences, Engineering, or related field
Nice to have: Lean
Nice to have: Six Sigma
Nice to have: continuous improvement methodologies
Lead the design, implementation, maintenance, and continuous improvement of the site Quality Management System (QMS) to ensure compliance with applicable regulations and corporate quality standards.
Responsibilities
Own and continuously improve the QMS (policies, SOPs, work instructions, records) to align with cGxP expectations and corporate requirements.
Lead CAPA, nonconformance, deviation, change control, complaint handling, and recall readiness processes; ensure timely investigation, root-cause analysis, and effective remediation.
Develop and maintain a risk-based approach to quality (FMEA, QRM) and integrate risk management into product and process decisions.
Oversee internal and supplier audit programs; plan, coordinate, and lead internal and external audits and ensure timely closure of findings.
Support supplier qualification and ongoing supplier quality oversight, including audits, performance monitoring, and corrective actions.
Requirements
Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
The Senior Quality Engineer is responsible for establishing, managing, and continuously improving the supplier quality program as the company commercializes its first product. While supplier quality is the core focus of this role, the Sr. QE is expected to contribute to the broader quality function as needed, including support for internal audits, CAPA, nonconformance management, and quality system improvements.
Compensation
The expected salary range for this position is $120,000-$135,000, plus comprehensive benefits and equity.
Responsibilities
Lead the qualification of new suppliers, including the development and execution of Supplier Qualification Plans (SQPs) and associated audits.
Evaluate supplier quality systems, manufacturing capabilities, and risk profiles through desk assessments, on-site audits, and technical reviews.
Manage Approved Supplier List (ASL) maintenance and ensure supplier files are complete, current, and compliant with QMS requirements.
Collaborate with Procurement and R&D to identify, evaluate, and qualify suppliers for new product introductions and design changes.
Develop, implement, and maintain Incoming Quality Control (IQC) processes, inspection plans, and acceptance criteria for purchased components and materials.
Requirements
Bachelor's degree required in Engineering, Materials Science, Biomedical Engineering, or a related technical discipline
Nice to have: advanced degree a plus
Nice to have: ASQ Certified Quality Engineer (CQE)
As a Quality Assurance Validation & Data Integrity Specialist, you will serve as an independent quality partner responsible for providing oversight and guidance across validation, qualification, and data integrity activities.
Compensation
The estimated base salary for this position is $88,000 - $121,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.
Responsibilities
Provide quality assurance leadership for validation and qualification projects
Review and approve validation, qualification, and lifecycle documentation
The Quality Systems Specialist II is responsible for ownership and continuous improvement of multiple elements of Elucent Medical's quality management system, with primary ownership of the Corrective and Preventive Action (CAPA) and internal audit programs.
Compensation
Pay Range: $85,000-$100,000 based on experience
Responsibilities
Assures all Quality Systems documentation and Record keeping activities are carried out and completed in compliance with established procedures and work instructions.
Serves as system owner for two or more quality system elements (e.g., Document control, Training, CAPA, audit, management review, etc.).
Supports completion of DCRs, CAPA, and Corrections in a timely manner.
Plans, schedules, and leads the internal audit program, including audit execution, reporting, and follow-up of findings to closure.
Controls and maintains externally supplied documentation other than prints and specifications, as required.
Requirements
Bachelor's degree in engineering, life sciences, or a related technical field
Nice to have: ISO 13485 Lead Auditor certification
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