16 часов назад
Supervisor Lab (Medical Devices)
79 000 - 119 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Supervisor Lab (Medical Devices): Directing chemical and microbiological testing of raw materials, in-process materials, and finished goods with an accent on FDA, ISO, ICH, and Good Manufacturing Practice compliance. Focus on leading laboratory staff, investigating quality failures, improving laboratory processes, and preparing technical documentation for regulated operations.
Location: Mundelein, Illinois; 2nd shift, 3:00 PM–11:00 PM; business travel up to 10%
Salary: $79,000–$119,000 annual, plus bonus and/or incentive eligibility
Company
is a healthcare products organization with a growing worldwide operation and a focus on medical, drug, and device manufacturing.
What you will do
- Direct and coordinate chemical and microbiological testing of raw materials, in-process materials, finished goods, stability samples, and project materials.
- Lead daily laboratory activities, assign work, monitor completion, and coordinate operations with other departments.
- Serve as a technical liaison between quality control, internal departments, vendors, contractors, suppliers, and customers.
- Participate in out-of-specification and failure investigations, troubleshoot quality concerns, and recommend corrective actions.
- Write and review deviation reports, testing protocols, trend analyses, SOPs, batch production records, and other quality documentation.
- Manage hiring, performance reviews, training, staff development, personnel planning, and laboratory budgeting.
Requirements
- Bachelor’s degree in Chemistry, Microbiology, Engineering, or another technical discipline.
- At least 3 years of laboratory experience in the medical drug or device industry.
- Experience mentoring junior staff and applying laboratory quality systems and regulatory requirements.
- Knowledge of ISO 13485, 21 CFR Part 210/211, and QSR Part 820.
- Technical writing experience in an FDA-regulated industry.
- Availability for the 2nd shift from 3:00 PM to 11:00 PM and up to 10% business travel.
Nice to have
- At least 2 years of experience in a laboratory supervisory or other technical supervisory role.
Culture & Benefits
- Competitive total rewards package with bonus and/or incentive eligibility.
- Health insurance, life and disability insurance, 401(k) contributions, and paid time off for eligible employees.
- Continuing education and training opportunities.
- Inclusive workplace focused on belonging, career growth, and employee development.
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