Integra LifeSciences
Staff Design & Reliability Assurance Quality Engineer
Integra LifeSciences, Mansfield, Ohio, United States, 44904
Overview
Sr Design & Reliability Assurance Quality Engineer
Join to apply for the
Sr Design & Reliability Assurance Quality Engineer
role at
Integra LifeSciences .
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Responsibilities
Lead and/or support the design and development of medical devices in close collaboration with R&D and external partners, including software requirements and electrical/software architectures
Lead and/or support risk analysis activities (FMEAs and SHAs). Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis).
Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes.
Proficiency in Design / Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control.
Conducts, and supports the development of test methods in equipment, process, and product qualifications/validations.
Support transfer to manufacturing activities both in product development and base business
Contributes to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions.
Develop inspection methodology and acceptance criteria for inspection sampling plans
Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc.
Fulfill design control requirements compliant: software specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines
Support Design and Technical Review
Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing
Demonstrate project management and leadership abilities
Participate to internal and external audits.
Maintain the Quality System
Equal Employment Opportunity Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans.
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email careers@integralife.com.
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Join to apply for the
Sr Design & Reliability Assurance Quality Engineer
role at
Integra LifeSciences .
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Responsibilities
Lead and/or support the design and development of medical devices in close collaboration with R&D and external partners, including software requirements and electrical/software architectures
Lead and/or support risk analysis activities (FMEAs and SHAs). Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis).
Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes.
Proficiency in Design / Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control.
Conducts, and supports the development of test methods in equipment, process, and product qualifications/validations.
Support transfer to manufacturing activities both in product development and base business
Contributes to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions.
Develop inspection methodology and acceptance criteria for inspection sampling plans
Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc.
Fulfill design control requirements compliant: software specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines
Support Design and Technical Review
Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing
Demonstrate project management and leadership abilities
Participate to internal and external audits.
Maintain the Quality System
Equal Employment Opportunity Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans.
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email careers@integralife.com.
#J-18808-Ljbffr