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Quality Assurance Specialist

1 month ago


Havre de Grace, Maryland, United States Entegee Full time

Job Title: Quality Engineer

Job Summary:

The Quality Engineer plays a crucial role in ensuring the safety and quality of laboratory operations. This position involves working closely with engineering to enhance lab equipment and providing essential testing support for new product releases.

Key Responsibilities:

  • Apply quality and statistical principles to maintain safety and quality systems within laboratory and site operations.
  • Write standard operating procedures (SOPs) and test procedures, data sheets documents.
  • Provide oversight for Calibration program.
  • Conduct customer-specific tests, generate test data reports, and collaborate with the Technical Support Department.
  • Ensure the effective operation and maintenance of all laboratory equipment, adhering to regulatory requirements.
  • Develop and maintain standard operating procedures to comply with regulatory and AS9100 requirements.
  • Evaluate new equipment and raw materials for safety compliance.
  • Oversee procurement of supplies and preventive maintenance of facility equipment.
  • Provide technical assistance via various communication channels.
  • Complete technical product reports and reports on encountered product problems.
  • Facilitate open and effective communication between cross-functional teams.
  • Handle and test samples requiring adherence to OSHA and safety policies.
  • Address requests from management in a timely manner.
  • Conduct quality and safety audits as required.

Mandatory Qualifications:

  • Bachelor of Science (Engineering preferred).
  • 5-10 years' experience in quality/manufacturing/process engineering.
  • Previous experience in quality/process engineering function in manufacturing environment and proficient in ERP, Laboratory Management software, quality systems, and Management of Change.
  • Continuous improvement background with demonstrated experience in problem-solving and root cause analysis.
  • Knowledge of statistical methods, standards, and execution of standards.
  • Knowledge of quality systems, ISO 9001/AS9100 requirements.
  • Experience in material/analytical testing.
  • Understanding manufacturing processes and value chain.

Preferred Qualifications:

  • Six Sigma Black Belt certification (preferred).

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and 401K plan.

The Company will consider qualified applicants with arrest and conviction records.