13 дней назад
Associate Director, Risk Management
135 000 - 168 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Risk Management (Medical Devices and Pharmaceuticals): Leading risk management systems for pharmaceutical products, medical devices, and combination products with an accent on product quality, patient safety, regulatory compliance, and statistical methodologies. Focus on managing risk specialists and applied statisticians, harmonizing global practices, and implementing solutions aligned with ISO 14971 and ICH Q9.
Location: Hybrid in Bethlehem, Pennsylvania, United States. Relocation is not available.
Salary: $135,000–$168,000 per year
Company
Medical develops, manufactures, and markets medical products and services, including infusion therapy, pain management, nutrition, dialysis, ostomy, and wound care solutions.
What you will do
- Lead and continuously improve risk management systems across the product lifecycle.
- Identify and mitigate product and process risks supporting quality, safety, and operational excellence.
- Manage and develop Risk Management Specialists and Applied Statisticians.
- Apply risk management and statistical tools to improve product reliability and manufacturing performance.
- Collaborate with global organizations to standardize practices and implement harmonized electronic systems.
- Ensure compliance with applicable industry regulations and standards.
Requirements
- Bachelor’s degree in Engineering, Quality, Statistics, Life Sciences, or a related field.
- At least 6 years of experience in risk management, quality, reliability, engineering, or a related discipline.
- Experience leading complex projects and continuous improvement initiatives.
- Expertise in risk management within pharmaceutical, medical device, or combination product industries.
- Advanced knowledge of statistics, quality systems, and continuous improvement methodologies.
- Strong leadership, analytical, communication, and cross-functional collaboration skills.
Nice to have
- Master’s degree.
- Professional certification in Risk Management, Quality, Reliability, or a related field.
- Experience managing technical or quality-focused teams.
- Experience with usability and cybersecurity risk management.
Culture & Benefits
- Healthcare benefits.
- 401(k) plan.
- Tuition reimbursement.
- Focus on continuous improvement, patient safety, and environmental safety.
- Collaboration with global organizations.
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