1 день назад
Supplier Quality Manager (Medical Devices)
100 000 - 125 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Supplier Quality Manager (Medical Devices): Managing supplier qualification, audits, quality agreements, and incoming inspection for pharmaceutical drug delivery device manufacturing with an accent on supplier performance, regulatory compliance, and continuous improvement. Focus on applying CAPA, FMEA, Six Sigma, SPC, and statistical methods to resolve non-conformities, reduce supply-chain risk, and maintain ISO and FDA quality systems.
Location: Onsite in Buffalo Grove, Illinois, United States; up to 40% travel required.
Salary: $100,000–$125,000 USD per year.
Company
is a global manufacturer of complex drug delivery systems and custom manufacturing solutions for the pharmaceutical industry, including inhalation, injection, nasal, dermal, and ophthalmic devices.
What you will do
- Plan, coordinate, and manage supplier quality evaluations, audits, and qualification activities.
- Interpret supplier requirements, manage quality agreements, and work with procurement, supply chain, engineering, manufacturing, and suppliers to improve performance.
- Lead continuous improvement initiatives using Six Sigma tools and resolve quality-system inefficiencies.
- Apply CAPA, FMEA, design of experiments, cause-and-effect analysis, flow charts, and SPC to investigate failures and non-conformities.
- Analyze supplier quality metrics, oversee incoming inspection, and manage issues related to supplied materials.
- Support ISO and FDA QMSR compliance, prepare monthly reports, and assist the Plant Quality Manager with quality objectives.
Requirements
- Bachelor’s degree in engineering, science, or a related field.
- At least 5 years of experience in a quality position.
- Advanced mathematical concepts and intermediate statistical knowledge.
- Ability to lift up to 40 pounds repetitively, push and pull items, and stand or walk for extended periods during the shift.
- Must be eligible to work in the United States.
- Ability to work independently and connect individual responsibilities with Quality department objectives.
Nice to have
- Medical device industry experience.
- Formal quality certification such as CQM or CQE.
- Six Sigma Black Belt training or certification.
- At least 3 years of supervisory experience in a similar environment.
- Microsoft Office and SAP experience, leadership, and strong interpersonal communication skills.
Culture & Benefits
- Work in a clean manufacturing environment with moderate noise and required cleanroom apparel.
- Contribute to products designed to improve patient treatment adherence and quality of life.
- Work within an international pharmaceutical device manufacturing group.
- US employee benefits are offered.
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