Job Title : Sr Product Quality Engineer

In this role, you have the opportunity to

• The Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle.

• The Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.

• The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes

You are responsible to

• Be responsible for the design control in Sustaining Project Quality Assurance

• Ensures that appropriate Quality Plans are made that include all stages of the life cycle of the product and supports Quality Plan design

• Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs

• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and all design-related activities during the product/system life cycle

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

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

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

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

• Ensure product-development processes and documentation meet Quality System requirements in relevant regulations, e.g. CFR 820.30, and ISO13485. Drive project decision direction toward compliance, cross-functionally and globally. (Process)

• Ensure that program documentation (Design History File) is created, controlled, and archived per the Quality System. (Process)

• Lead, prepare, and participate/be the main escort in internal and external audits

• Frequently interacts with supervisors and functional peer groups. Interaction normally requires the ability to gain the cooperation of others, conducting presentations of technical information concerning specific projects or schedules.

To succeed in this role, you should have the following background, basic skills or experience

• Bachelor's/Master's in Engineering with minimum of 6-8 years work experience in a Medtech industry

• Strong quality assurance management experience, minimum 5 years in quality assurance - Mandatory

• Strong design control and new product development experience - Mandatory

• Risk Management

• Professional knowledge in the area of ISO 13485, FDA 820, ISO14971, FDA/MDR/MDSAP - Mandatory

• Strong analytical abilities

• Strong communication, problem-solving, and continuous improvement.

• Fluent in English both in writing and speaking

• Have experience in the medical industry or highly regulated industry

• Strong Influence Skills, Presentation Skills and Conflict Resolving Skills.

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