Technical Quality Assurance Manager

3 days ago

Singapore BECTON DICKINSON MEDICAL PRODUCTS PTE LTD Full time

Overview

Becton Dickinson Medical Products PTE LTD, a leading global medical technology company, seeks an experienced Technical Quality Assurance Manager to join our team. This role will play a critical part in ensuring the successful completion of projects and programs by performing quality assurance activities.

About Us

We are committed to delivering state-of-the-art technology and cutting-edge research to combat infectious diseases. Our network of professionals collaborates on effective measures to deliver enhanced patient quality, such as lower healthcare delivery costs, improved healthcare and safety, and expanded healthcare for all.

Job Summary

This position is responsible for applying technical expertise and knowledge of advanced statistical techniques to support engineering work in the design, development, and evaluation of medical devices. The successful candidate will ensure compliance with 21 CFR 820, ISO 13485, and EN requirements and contribute to the development and implementation of quality systems and procedures.

Key Responsibilities:

  • Leads or assists in the development and continuous improvement of quality systems for R&D in compliance with regulatory requirements.
  • Ensures compliance with BD quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles.
  • Contributes as a team member on development projects carrying out assigned quality assurance responsibilities.
  • Promotes advanced understanding of customer needs and processes to ensure relevant and innovative product development.
  • Applies Design to Cost and Design for Manufacturability methods to support project leaders in achieving project objectives.
  • Supports cross-functional planning, coordination, and reviews.
  • Leads Risk Management plans/reports and situational analyses for products under design authority.
  • Promotes the use of statistics in the testing and control of quality and applies Six Sigma methodology to support product development processes.
  • Actively mentors associates in related technical roles, providing technical direction and frequent feedback.
  • Contributes to assembling and maintaining the Design History File (DHF).
  • Supports quality initiatives for plant issues.

Requirements

To be considered for this role, you should possess:

  • A Bachelor's degree in mechanical engineering, biomedical engineering, or a related engineering discipline.
  • At least 5 years of working experience in the medical device industry.
  • A good working knowledge of medical device regulations and practices (ISO 13485, 21 CFR 820, etc.).
  • A good knowledge and understanding of process development, total quality tools, and continual improvement approaches.
  • A complete understanding of quality assurance principles and concepts, total quality tools, continual improvement approaches, industry practices, and standards.
  • An advanced understanding of design control, disciplined product development processes, regulatory, and quality requirements.
  • An advanced knowledge of Six Sigma methodology, statistical methods, and analysis.
  • The ability to translate customer needs into design inputs and specifications.

What We Offer

As a valued member of our team, you can expect:

  • A competitive salary range: SGD $120,000 - $180,000 per annum, depending on experience.
  • Ongoing professional development opportunities.
  • A collaborative and dynamic work environment.
  • A comprehensive benefits package, including medical and dental insurance, retirement savings plan, and paid time off.

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