Experience Inc. Jobs

Purpose:

• The Product Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle. The Product Quality Engineer provides independent oversight of the design planning process, design V&V activities, design transfer and product production, and performance in the field to ensure that all design requirements are effectively met. The Product Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product production processes.

You are responsible for

• Ensure that appropriate quality plans are made that include all stages of the lifecycle of the product and supports Quality plan design

• Provide effective oversight of the execution of the Design Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle

• Performs independent technical assessment on product quality performance and post-market product quality analysis

• Can Lead quality related problem solving and root cause analysis during design and manufacturing

• Use post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiate field actions when required

• Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone

• Execute risk management activities, biocompatibility testing, product failure rate and reliability estimations.

To succeed in this role, you should have the following skills and experience

• Bachelor’s degree in a scientific discipline, Engineering highly preferred.

• 3+ years of Quality Engineering experience, experience within Medical Device or other highly regulated industry is preferred. Knowledge of 21CFR 820 and ISO 13485 design controls is preferred.

• Previous experience leading as a quality Subject Matter expert within design

• Experience in performing timely, quality engineering tasks like:

• Assessing quality plans and product designs

• Reviewing test and other performance data

• Analyses of market feedback

• Leading root cause analysis and quality problem solving.

• Independently produce and complete Quality Engineering Documents. Can develop & administer quality related project plans and schedules.

• Individual contributor who acts as mentor to junior team members on quality related projects or issues.

• Good English and Chinese languages skills.

• Work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for obtaining solutions.

• Desirable: Quality Engineering or Quality Reliability Engineering certification.