1 час назад
Manager, Quality (Medical Devices)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, Quality (Medical Devices) (ISO 13485, FDA QSR, EU MDR): Managing a quality management system and regulatory compliance for medical device manufacturing with an accent on audits, supplier quality, risk management, and continuous improvement. Focus on leading quality teams, monitoring manufacturing metrics, and integrating quality requirements across R&D, engineering, and production.
Location: On-site in Pasir Gudang, Johor, Malaysia
Company
is a Danaher operating company that develops and produces medical monitoring technologies, sensors, patient monitors, and connectivity solutions.
What you will do
- Develop, implement, and manage a quality management system compliant with ISO 13485 and applicable FDA requirements.
- Monitor medical device regulations, standards, and guidelines to maintain product compliance.
- Lead quality audits, assessments, inspections, and supplier qualification and evaluation.
- Implement risk management processes for product quality and safety.
- Define and track quality metrics for the QMS and manufacturing processes.
- Collaborate with R&D, manufacturing, engineering, and other functions throughout the product lifecycle.
Requirements
- Bachelor’s or master’s degree in engineering, Quality Management, Life Sciences, or a related field.
- Extensive quality management experience in medical device or pharmaceutical manufacturing.
- In-depth knowledge of ISO 13485, FDA QSR, EU MDR, and related regulatory standards.
- Strong experience with Six Sigma, Lean, and other quality improvement methodologies.
- Proven experience managing and leading quality teams.
- Strong problem-solving, analytical, decision-making, communication, and cross-functional collaboration skills.
Culture & Benefits
- Full-time employment within Danaher’s continuous improvement environment.
- Comprehensive healthcare and paid time-off programs.
- Eligibility for incentive pay of up to 10% of annual base salary, subject to applicable conditions and performance criteria.
- Opportunity to contribute to medical technologies that support patient care.
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