Quality Inspector/Technician II

The Quality Inspector provides operational support related to instrument verification, manufacturing, troubleshooting, and incoming, in process and outgoing release of product. Supports quality assessments of internal operations to analyze compliance and assess risks. Works under general supervision.

• Performs incoming inspection of outsourced products, in-process manufacturing inspections and final release inspections. Conducts these activities in compliance with Standard Operating Procedures and Manufacturing Batch Records outlined in MaxCyte’s Quality Management System
• Ensures that production records and testing results are complete, accurate, and documented according to written procedures and requirements
• Generates Nonconforming Reports to record and ensure that products meet MaxCyte standards and requirements
• Document inspection and test results according to established procedures and following Good Documentation Practices
• Provides operational support and monitors and inspects assembly process control
• Provides quality support to facilitate investigations, root cause analysis and corrective action/preventive action (CAPA) implementation
• Supports internal and external audits and quality system certification. Report sand documents nonconforming materials in the QMS system. Participates in audits as needed
• Supports ongoing product enhancement activities; to include changing specifications to make product improvements
• Interface with other functions and departments as needed
• Complies with all applicable policies regarding health, safety, and the environment

• AA in Mechanical, Electrical Engineering or other related discipline with at least 5-8 -years of hands-on assembly and testing of instrumentation systems specific to medical devices and/or laboratory equipment; or equivalent
• Previous inspection experience required
• Demonstrated experience troubleshooting mechanical and electrical components
• Understands manufacturing processes and design control and able to apply to the work environment
• Proven knowledge and understanding of QSR, GMP, and ISO requirements
• Demonstrated computer skills. Experience using MS Office (Word, Excel, PowerPoint)
• Ability to work on a team and independently
• Robust verbal, written, and interpersonal skills
• Proven organizational and time management skills
• Customer oriented; has a “do what it takes” attitude to meet deadlines

Note: To the extent permissible under applicable law, candidates will be required to show proof of being fully vaccinated against COVID-19 upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law.