4 дня назад
Quality Engineer I (Healthcare Manufacturing)
76 000 - 95 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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