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Philips

Makes medical devices and personal health products

Senior Design Quality Manager

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timeSuzhou, Jiangsu, ChinaNo salary listed

About the Job

Requirements

  • A Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent is required.
  • A minimum of 5 years of experience with a Bachelor's degree or 3 years of experience with a Master's degree in Quality Engineering, Safety Engineering, Process Engineering, or equivalent is required.

Responsibilities

  • Use advanced risk assessment methodologies such as Failure Mode and Effects Analysis and Fault Tree Analysis to identify potential hazards, assess risk severity and probability, and develop risk mitigation strategies.
  • Review and improve product safety processes and procedures, recommend process enhancements and resource allocation adjustments, and optimize team performance and departmental goals.
  • Collaborate with regulatory bodies and industry associations to forecast regulatory trends and influence industry standards; publish research findings and contribute to industry publications.
  • Serve as a subject matter expert in product safety, provide strategic counsel to stakeholders, and represent Philips in regulatory discussions and industry working groups.
  • Lead development and implementation of a product safety strategy aligned with business objectives and safety across product lines.
  • Develop approaches to mitigate emerging safety trends and technological risks, and influence product roadmaps to address risks before development begins.
  • Participate in discussions and negotiations with regulatory authorities to achieve safety outcomes while ensuring business feasibility and uninterrupted operations.
  • Guide team members on complex product safety challenges, share subject matter knowledge, and encourage ownership of solutions.
  • Oversee and optimize the product safety management system, ensuring traceability of risk management activities and compliance with quality standards.
  • Lead and conduct internal audits to identify and address system gaps and promote continuous improvement.
  • Manage team talent, employee selection, performance management, compensation management, career development, and operational management.

Desired Qualifications

  • Safety Quality Management.
  • Data Analysis and Interpretation.
  • Design for Quality.
  • Root Cause Analysis.
  • CAPA Methodologies.
  • Regulatory Requirements.
  • Privacy, Safety and Security Risk Assessment.
  • Technical Documentation.
  • Continuous Improvement.
  • Product Quality and Reliability.
  • Product Lifecycle Management.
  • Business Acumen.
  • People Management.

About the Company

Philips

Makes medical devices and personal health products

Philips makes medical equipment and software for hospitals and care providers, along with personal health products for consumers. Its hospital portfolio spans MRI and CT scanners, ultrasound, image-guided treatment systems and patient monitors, while Sonicare and Avent cover oral health and baby care. Clinical software connects medical images and patient data across care teams, and the company earns revenue from equipment, software, maintenance and consumer product sales. It works with health systems through long-term technology and service partnerships, including solutions for care at home. Founded in 1891, Philips is headquartered in Amsterdam, the Netherlands.

Company size
10,001+
Company stage
Acquired
Total funding
$164.7M
Headquarters
Andover, MN
Founded
1891

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