A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system.
You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance.
You will monitor quality assurance efforts to ensure that the company’s products conform to quality standards. You will partner with research/development and manufacturing engineering during new product start-ups and establish checkpoints for testing new products and processes.
The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.
Ensure company’s adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications. Manage new product Design History Files.
Develops and documents test plan protocols, test procedures, and test reports.
Perform tests according to various protocol requirements.
Lead completion of risk management and risk analysis including FMEA.
Devise design verification and design validation plans for products based on performance specifications and risk analysis.
Qualifications
BS Engineering degree.
3+ years of related experience in regulated environment.
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
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Seniority level
Entry level
Employment type
Contract
Job function
Engineering
Industries
Hospitals and Health Care
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