Quality Engineer

Job Title

Responsibilities

Key Responsibilities

Be a part of sustaining project team and work in the design quality engineering across the entire product cycle.

Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable)

Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts (if required) for commercial products.

Manage electronic document control and version control on all project related documents.

Ensure adherence to the quality systems and design assurance SOPs and customer's PLCP.

Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.

Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

Acts as an effective communicator or team member in supporting quality disciplines, decisions, and practices.

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.