A development quality engineer assures new or modified products conform to requirements and establishes compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
Execute on-time completion of design control deliverables · Design verification and validation test planning · Writing design verification and validation test protocols, execution and reports · Design input output trace matrix · Design History File organization · Customer, system, and product requirement review · Regulatory responses and submissions · Risk/hazard analysis and risk management plan/reports · Design specification reviews · Quality plans · Design change plan/reports · Investigate internal and external audit findings and write responses · Corrective and preventive action resolution · Complete document change requests
Solid communication and interpersonal skills · Strong verbal communications and written communications with ability to effectively communicate at multiple levels in the Organization · Advanced computer skills, including very strong report writing skills and document control database navigation and use ·
Ability to work within a team and as an individual contributor in a fast-paced, changing environment · Self-directed: Multitasks, prioritizes and meets deadlines in timely manner with minimal oversight · Strong organizational and follow-up skills, as well as attention to detail
Medical device/ Pharma Quality engineering experience and demonstrated use of Quality tools/methodologies. Quality,CAPA,Design,Medical Device,Pharma,FDA