Job Description:
Description:
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
MaxCyte is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
PI255454990
Salary:
$134,576.00More jobs in Rockville, Maryland
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