4 дня назад
Dir, QA (Product Quality)
154 000 - 231 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Dir, QA (Product Quality) (Medical Devices/Quality Systems): Leading product quality and compliance strategy for medical device and combination product platforms with an accent on design controls, risk management, supplier quality, and FDA/ISO requirements. Focus on directing quality teams, developing product specifications and QA programs, and ensuring compliance with QSR, GMP, ISO 13485, ISO 14971, MDSAP, and MDR.
Location: Northfield, Illinois, United States; travel up to 30% within the state, nationally, and internationally.
Salary: $154,000–$231,000 annual, plus bonus and/or incentive eligibility.
Company
is a healthcare products organization offering medical and regulated product solutions through a growing worldwide operation.
What you will do
- Lead quality teams and establish long-term strategic, tactical, and operational plans for assigned departments.
- Direct product specifications, testing requirements, inspection methods, qualification processes, and supplier quality activities.
- Develop and implement quality strategies based on quarterly management reviews.
- Collaborate with suppliers, manufacturing partners, product managers, and senior leaders to deliver compliant products and meet customer requirements.
- Oversee QSR compliance and audit readiness against FDA, ISO, and internal standards.
- Manage budgets, staffing, performance reviews, training, work assignments, and policy implementation.
Requirements
- Bachelor’s degree in Engineering, Science, or a technical field.
- At least 7 years of experience with medical device or drug combination product platforms, design controls, risk management, and regulated quality systems.
- At least 4 years of management experience; 6 years preferred.
- Technical knowledge of 21 CFR 820, ISO 13485, ISO 14971, MDSAP, MDR, QSR, and GMP requirements.
- Ability to analyze and report data, coordinate concurrent projects, manage competing priorities, and meet critical deadlines.
- Advanced Microsoft Excel skills and willingness to travel up to 30% for business purposes.
Nice to have
- At least 8 years of related experience in medical device, pharmaceutical, food, cosmetic, or personal products industries.
Culture & Benefits
- Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
- Access to an Employee Assistance Program, Employee Resource Groups, and Employee Service Corp.
- Continuing education and training opportunities.
- Inclusive workplace focused on belonging, career growth, and equal employment opportunity.
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