Quality Assurance Specialist is responsible for supporting cross-functional departments to provide quality guidance. Perform investigations and troubleshooting for nonconformances and corrective and preventative actions, assist Quality Control.

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

• Initiating nonconformance’s and CAPAs, and conduct investigation and coordinate necessary activities with other departments and/or external parties.

• On-going monitoring and management of quality system efficiencies

• Lead the development, implementation, and continuous improvement of quality management systems (QMS)

• Pro-actively identifies and mitigates key cross-functional and vendor issues

• Maintains and monitors key quality systems such as deviations, investigations, CAPA; review of trended data to identify improvements.

• Review QC data generated as to the acceptance to established product specifications or to request adjustments to specifications

• Ensure that the final product satisfies the product requirements and meet end-user expectations

• Participate in internal assessments and audits where necessary

• Contributes to the development of the Quality Assurance function by initiating and driving positive change with the oversight of new initiatives, systems or directives for ongoing process improvement and implementation of best practices

• Write/revise standard quality control operating procedures and other documentations as necessary

• Reviews document and process changes, as needed

• Support Quality Control as needed

Qualifications

Baseline skills/experiences/attributes:

• The candidate will have 5+ years experience in Quality Assurance role.

• Advanced familiarity with IVD, biotech or sequencing industry manufacturing processes and procedures including acceptance activities, production and process controls, identification and traceability, quality auditing, etc.

• Experienced in writing procedures, protocols, and reports.

• Experience in driving investigations to root cause

• Drive for quality: They must have a drive to continuously improve processes for improved performance

• Achieving impossible timelines, through a combination of superior planning, proven assessment of risk and the ability to inspire and enable others to move fast

• Partnership and collaboration, ensuring relationships are a forefront of our strategy, emphasizing the company and team over personal goals, and the ability to

• Communication, both oral and written, with the ability to communicate frequently, clearly, and timely while keeping both internal and external parties aligned to deliver impact at pace

• Problem solving, with very strong analytical skills which can be utilized to proactively identify and address issues with a solution-oriented approach with excellent time management skills

The estimated base salary range for this role based in the United States of America is: $90,000 - $115,000. 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.