Manager - Design Quality Assurance
49d ago

Job Description

In this role, the DQA Manager (Design Quality Assurance) provides guidance of Design Controls and the PRP process to the engineering core teams.

The DQA Manager will recommend / promote new testing methodologies and approaches required to complete reliability analyses of device designs.

The DQA Manager will provide guidance for development of manufacturing test / evaluation methods and process validation.

You are responsible for :

  • Support activities required to ensure reliability of the design. Work with key stakeholders to design, implement and maintain business solutions to address management of reliability requirements, clinical relevant test methods and Design Verification test plans, execution and reports
  • Establish and oversee systems for the escalation, monitoring and communication of key quality issues
  • Establish processes to ensure findings, risks, recommendations and outcomes are clearly documented and communicated
  • Facilitate the identification and deployment of resources to investigate and resolve issues in a timely and effective manner.
  • Contribute quality and compliance expertise and guidance to teams responsible for addressing specific quality issues.
  • Provide oversight and monitoring of all phases of design to ensure compliance and timely resolution. Support and lead FMEA / Risk Management processes and activities.
  • Work with business process owners to devise appropriate metrics to improve product and process
  • Establish Quality Assurance process metrics. Trend, analyze, and report on quality data; develop recommendations based on data analysis
  • Support Post Market Product Assurance and audit groups in post-market activities.
  • Work with business process owners to identify and implement solutions to track cost of poor quality . Evaluate for completeness, effectiveness and proper identification of root cause
  • Monitor the effectiveness of implemented actions and overall effectiveness of the system
  • Establish and support best practices for problem solving, root cause analysis, and solution selection tools
  • Provide subject matter expertise during internal and external quality system audits.
  • Provide management with plans and status updates on assigned responsibilities and goals and escalate issues in a timely fashion
  • To succeed in this role, you should have the following skills and experience :

    Bachelor’s degree in engineering or science discipline (must have)

    Experience in meeting requirements of ISO 13485, CFR 820, ISO 14971

    Strong project management and organizational skills and experience

    Knowledge of Microsoft Office products

    Experience in providing customer focused solutions

    Track record of successfully designing and deploying innovative quality systems and process

    Proven success in a position requiring highly effective communication, facilitation and negotiation skills

    Proven ability to lead cross functional teams to resolve complex issues

    Why should you join Philips ?

    Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum.

    Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

    To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog.

    Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.


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