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Full-timeDescriptionThe 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.
Requirements
- 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/yearBackground checks and reference checks are requiredPosition 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
