Quality Engineer
A Quality Engineer assures new or modified products perform the functions intended in a safe manner and establishes compliance with the quality system.
They collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored.
They are 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 and support on-time completion of Risk Management Deliverables (RMP/RMR, HA, DFMEA, UFMEA, and complaint data review/analysis).
Maintain Risk Management deliverables to ensure continued acceptability of product based on post market feedback.
Evaluate and update the Use, Design and Process FMEAs.
Drive creation of risk mitigation strategy and support the establishment of objective, measurable, discrete, and verifiable customer, and product requirements to meet that strategy.
Complete Document Change Request Reviews in a timely and objective manner.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Requirements
Bachelor level degree in engineering.
3+ years' experience with Risk Management, Design Controls, DFMEA, UFMEA, CAPA, Nonconformances etc.
Solid communication and interpersonal skills.
Some experience with ISO 14971, ISO 13485, medical device industry background highly preferred.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
As an equal opportunity employer, ICONMA prides itself on creating an employment environment that supports and encourages the abilities of all persons regardless of race, color, gender, age, sexual orientation, citizenship, or disability
Vish Ghanwani
P:
They collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored.
They are 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 and support on-time completion of Risk Management Deliverables (RMP/RMR, HA, DFMEA, UFMEA, and complaint data review/analysis).
Maintain Risk Management deliverables to ensure continued acceptability of product based on post market feedback.
Evaluate and update the Use, Design and Process FMEAs.
Drive creation of risk mitigation strategy and support the establishment of objective, measurable, discrete, and verifiable customer, and product requirements to meet that strategy.
Complete Document Change Request Reviews in a timely and objective manner.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Requirements
Bachelor level degree in engineering.
3+ years' experience with Risk Management, Design Controls, DFMEA, UFMEA, CAPA, Nonconformances etc.
Solid communication and interpersonal skills.
Some experience with ISO 14971, ISO 13485, medical device industry background highly preferred.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
As an equal opportunity employer, ICONMA prides itself on creating an employment environment that supports and encourages the abilities of all persons regardless of race, color, gender, age, sexual orientation, citizenship, or disability
Vish Ghanwani
P:
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