Quality Assurance Specialist Manager

3 days ago

Rockville, Maryland, United States MaxCyte Full time
About the Role

We are seeking a highly skilled Senior Quality Engineer to join our team at MaxCyte. As part of our production team, this individual will be responsible for establishing production standards for our products.

  • This person will provide critical support to the Quality and Regulatory Affairs team, ensuring seamless operations with minimal oversight.
  • They will coordinate activities of the Material Review Board (MRB) and offer technical assistance to facilitate quality investigations, root cause analysis, and implement corrective action/preventive action (CAPA) based on investigation findings.
  • The successful candidate will conduct out-of-specification investigations for cleanroom manufacturing activities and collaborate with the facilities and manufacturing teams to maintain cleanroom compliance with ISO standards.
  • They will adhere to activities that must comply with Standard Operating Procedures and Manufacturing Batch Records as outlined in MaxCyte's Quality Management System.
  • This person will initiate engineering change requests as the functional change owner and oversee the execution and implementation of proposed changes.
  • They will participate in identifying specifications for a given product and determine an appropriate level of variation and monitor quality assurance rates.
  • The Senior Quality Engineer will analyze reports and production data to identify trends and recommend updates to quality standards and procedures.
  • They will support internal and external audits and quality system certification by finding evidence that supports and documents processes to meet specifications and standards.
  • This individual will interact with the internal team to develop programs and solutions for vendors and suppliers.
  • They will collaborate with departments to analyze and resolve technical issues in accordance with quality standards.
  • The Senior Quality Engineer will draft and review procedures and work instructions for manufacturing and operations processes.
  • They will provide operational support and monitor assembly process control.
  • This person will evaluate and recommend process improvements using LEAN principles.
  • Supports ongoing product enhancement activities by troubleshooting and improving performance.

Requirements:

  • A Master's degree or equivalent in Mechanical, Instrumentation, Biomedical, or Electrical Engineering, Management Information Systems, or related fields, along with 48 months of experience as a Quality Engineer, Manufacturing Engineer, or related field. Alternatively, a Bachelor's degree or equivalent in the above-stated fields plus 96 months of progressively responsible experience in the same occupations is acceptable.
  • This candidate must possess hands-on assembly and testing of instrumentation systems specific to medical devices and/or laboratory equipment or equivalent, as well as 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, QSR, GMP, and ISO requirements, as well as a lead auditor certificate are also required.
Estimated Salary

The estimated annual salary for this position is $134,576.00.

Benefits

MaxCyte offers a comprehensive benefits package, including medical, dental, vision, life insurance, vacation, holidays, tuition assistance, 401(k), stock options, and flexible spending accounts.

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