9 дней назад
Quality Associate II (Medical Devices)
88 000 - 110 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Associate II (Medical Devices): Implementing and improving quality systems, processes, and procedures for medical device manufacturing with an accent on process validation, product investigations, corrective actions, and regulatory compliance. Focus on leading technician training, making product conformance decisions, supporting Lean and continuous improvement projects, and sustaining cGMP and FDA manufacturing standards.
Location: Cleveland, Mississippi, United States; onsite. Applicants must be authorized to work for any employer in the U.S.; visa sponsorship or transfer of sponsorship is not available.
Salary: $88,000–$110,000 annually
Company
Medical technology company focused on healthcare products and solutions that help save and sustain lives.
What you will do
- Implement, maintain, and improve quality systems, processes, and procedures in the Devices departments.
- Lead, train, and cross-train technicians while supporting hiring, onboarding, performance management, and a collaborative work environment.
- Support process validation, process capability, process control studies, equipment upgrades, and new system implementation.
- Investigate customer complaints and nonconformances, perform defect and failure analysis, and implement corrective actions.
- Trend quality metrics, make independent product-conformance decisions, and communicate shift activities and issues clearly.
- Support Lean, problem-solving, process-control, project-management, and continuous-improvement initiatives while maintaining safe and compliant operations.
Requirements
- Bachelor’s degree in Microbiology, Biology, Chemistry, or Engineering.
- Knowledge of quality systems and procedures and experience with FDA-regulated manufacturing.
- Knowledge of rigorous quality standards, SOPs, and current good manufacturing practices (cGMP).
- Ability to communicate effectively, work independently, collaborate cross-functionally, and manage multiple projects.
- Ability to travel as needed and perform duties involving prolonged sitting, standing, walking, reaching, and bending.
- U.S. work authorization required; visa sponsorship is not available.
Nice to have
- Six Sigma Green Belt certification or equivalent.
- Lean manufacturing skills and experience.
Culture & Benefits
- Full-time employment with medical and dental coverage beginning on day one.
- 401(k) retirement plan with company matching and employee stock purchase plan.
- Paid holidays, paid time off, family and medical leave, and paid parental leave.
- Flexible spending accounts, educational assistance, disability insurance, childcare benefits, and employee assistance programs.
- Safety-focused work environment using 6S principles.
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