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4 дня назад

Quality Engineer I (Healthcare Manufacturing)

76 000 - 95 000$
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Quality Engineer I (Healthcare Manufacturing): Performing process validation, capability studies, and quality improvement for healthcare manufacturing operations with an accent on FDA compliance, cGMP, statistical analysis, and computer-system validation. Focus on validating facility and application systems, developing process controls, and implementing automation and process improvements across manufacturing and quality teams.

Location: Cleveland, Mississippi, United States

Salary: $76,000–$95,000 annually

Company

Healthcare manufacturing organization focused on products and systems that support patient health and safety.

What you will do

  • Perform process validation, process capability, and process control studies.
  • Drive quality and manufacturing projects using Lean, problem-solving, process control, and project management tools.
  • Support the development and implementation of new manufacturing processes and technologies.
  • Identify and develop process improvement projects, including automation and computerization.
  • Validate computer systems, applications, facility systems, upgrades, and replacements to meet FDA and regulatory quality requirements.
  • Write validation protocols and test cases, coordinate testing, implement application changes, support training, and maintain safe work areas using 6S principles.

Requirements

  • Bachelor's degree in Engineering, Computer Science, or another core science field.
  • 0–1 year of related experience, including in-house, co-op, or external experience.
  • Knowledge of applied statistical analysis for process and product capability studies.
  • Ability to collaborate with cross-functional teams, learn applications quickly, and work independently.
  • Ability to apply cGMP, quality standards, environmental health and safety regulations, and validation procedures.
  • Must be authorized to work for any employer in the United States; employment visa sponsorship or transfer is not available.

Nice to have

  • Experience with Wonderware, Allen-Bradley PLC, Access, or Microsoft Project.
  • ASQ CQE or CSQE certification, or equivalent.
  • Experience in quality assurance or the pharmaceutical industry.

Culture & Benefits

  • Full-time employment with medical and dental coverage beginning on day one.
  • Life, accident, disability, and business travel accident insurance.
  • 401(k) retirement plan with employee contributions and company matching, plus an employee stock purchase plan.
  • Educational assistance, paid holidays, paid time off, family and medical leave, and paid parental leave.
  • Additional commuting, childcare, employee assistance, and employee discount benefits.
  • Overtime may be required.

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