Product Quality Engineer

5 days ago

George Town, Penang, Malaysia Agilent Technologies Full time

Job Description

The Product Quality Engineer shares a passion for ensuring the highest quality experiences for our patients and customers. This position will be responsible for product quality investigation and Post Market Surveillance activities for Agilent products.

The daily tasks will include driving and leading product quality investigation from In Vitro Diagnostics (IVD) complaints and trend, consistently implementing high quality investigation by using appropriate root cause analysis methodologies and conducting thorough risk assessment, leading the product quality issue review with management team, and reviewing and aligning the CAPAs, Field Action, Critical Quality Incidents (CQIN) according to corporate procedures and guidance.

These activities will be completed through close collaboration with other quality, regulatory, and business functions across the company.

Under limited supervision/general direction and in accordance with all applicable federal, state and local laws/regulations and corporate procedures and guidelines, this position:

  • Applies advanced Quality and Scientific methodologies and principles to daily tasks and activities.
  • Applies relevant regulations, standards, GxP requirements, and industry best practices to assignments.
  • Acts as a subject matter expert in product quality investigation, plans and conducts product quality investigation activities with high technical responsibility.
  • Works closely with Complaints Management Center to ensure Genomics product complaints and trend investigations are completed on time.
  • Develops and drives key strategic quality initiatives throughout the organization, supports the execution of strategic vision or plan by collaborating with other quality partners to identify and standardize quality investigation competencies.
  • Lead and contribute the product quality investigation process implementation and improvement, as well as deliver product quality investigation training to the organization.
  • Establish, implement, and monitor annual product quality review (APQR) relevant product quality metrics for assigned products.
  • The quality engineer will also be involved with quality systems initiatives as a primary assignment or additional assignment. Generally, the projects will involve potentially greater business impact in the following areas:
    • Business improvement
    • Quality systems
    • Lifecycle management
    • Performs other duties assigned as needed.
    Qualifications
    • Bachelor's Degree in Engineering, Science, or related technical field from an accredited school is required. A relevant advanced Degree is preferred.
    • A total of 8+ years of work experience is expected. Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is preferred.
    • Experience working with ISO 13485, FDA CFR 21 Part 820 and ISO 14971.
    • Experience of working on IVD Post Market Surveillance and complaints investigation.
    • Leading and/or contributing to root cause investigations using various problem-solving techniques and tools and assessing the effectiveness of corrective actions.
    • Systematically driving root cause analysis with appropriate tools and methodologies (for example, DFMEA, Fishbone, Fault Tree Analysis) and Corrective Action / Preventive Action (CAPA) investigations.
    • Demonstrating a high level of proficiency in applying established quality tools and methods (for example, Six Sigma, Lean) to identify and realize new process introductions, as well as process and business improvements.
    • Experience of leading and presenting product quality issue investigation with management team.
    • Process and detail oriented as well as a proactive team player who's capable of working cross-functionally with people at all levels of the organization.
    • Full fluency in English on business level.
    Additional Details

    This job has a full time weekly schedule.

    Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

    Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

    Travel Required: 10% of the Time
    Shift: Day
    Duration: No End Date
    Job Function: Quality/Regulatory
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