The Senior Quality Engineer is part of the team that is responsible for establishing production standards for MaxCyte products by creating quality control systems and documenting product requirement specifications.

• Provides support to the Quality and Regulatory Affairs team and accomplishes work with little oversight.
• Coordinates activities of the Material Review Board (MRB) and provides technical support to facilitate quality investigations, root cause analysis, and implement corrective action/preventive action (CAPA) based on investigation findings.
• Conducts out-of-specification investigations for cleanroom manufacturing activities and annual validation of the cleanroom. Collaborates with the facilities and manufacturing teams to maintain cleanroom compliance with ISO standards.
• Adheres to activities that must comply with Standard Operating Procedures and Manufacturing Batch Records as outlined in MaxCyte’s Quality Management System.
• Initiates engineering change requests as the functional change owner and oversees the execution and implementation of the proposed changes.
• Participates in identifying the specifications for a given product and determines an appropriate level of variation and monitors quality assurance rates.
• Analyzes reports and production data to identify trends and recommends updates to quality standards and procedures.
• Supports internal and external (suppliers and vendors) audits and quality system certification by finding evidence that supports and documents processes to meet specifications and standards.
• Interacts with the internal team to develop programs and solutions for vendors and suppliers.
• Collaborates with departments to analyze and resolve technical issues in accordance with appropriate quality standards.
• Drafts and reviews procedures and work instructions for manufacturing and operations processes.
• Provides operational support and monitors assembly process control.
• Evaluate and recommend process improvements utilizing LEAN principles.
• Supports ongoing product enhancement activities by troubleshooting and improving performance. Complies with all applicable policies regarding health, safety, and the environment.

• Master's or equivalent in Mechanical, Instrumentation, Biomedical, or Electrical Engineering, Management Information Systems, or related and 48 months of experience as a/an Quality Engineer, Manufacturing Engineer, or related. In the alternative, we will accept a Bachelor's or equivalent in the above-stated fields plus 96 months of progressively responsible experience in the above-stated occupations.
• Additionally, all candidates must possess hands-on assembly and testing of instrumentation systems specific to medical devices and/or laboratory equipment or equivalent. Troubleshooting mechanical and electrical components.
  Resolving customer problems and issues through technical knowledge and troubleshooting skills. Quality Assurance Systems. Manufacturing processes and design control.
• LEAN manufacturing principles, and QSR, GMP, and ISO requirements.
• Lead auditor certificate required.
  

Min. Rate of Pay: $134,576.00/year

Background checks and reference checks are required

Position is based out of 9713 Key West Avenue, Rockville, MD 20850. Approximately 10% of travel for supplier and customer audits within the US is required.

Benefits offered: Medical, Dental, Vision, Life Insurance, Vacation, Holidays, Tuition assistance, 401(k) Stock Options [Equity (RSUs)] and Flexible spending account