SR. Quality Engineer II - Integra LifeSciences
Mansfield, MA
About the Job
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
+ Conduct benchmarking to develop more effective methods for improving quality.
+ Approve IQ, OQ, PQ, TMV or Software Validation
+ Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
+ Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
+ Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
+ Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
+ Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
It is also understood that an associate may receive special projects outside of this list.
DESIRED MINIMUM QUALIFICATIONS:
+ Minimum required education and experience: Bachelor's degree or equivalent with 8+ years of experience, Master degree with 5+ years of experience, Doctoral degree with 3+ years of experience
+ This position will require relevant experience working in manufacturing/operations.
+ In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
+ Experience with a proven track record of implementing appropriate risk mitigation.
+ Good technical understanding of manufacturing equipment and processes is required.
+ Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
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 (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
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 (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
+ Conduct benchmarking to develop more effective methods for improving quality.
+ Approve IQ, OQ, PQ, TMV or Software Validation
+ Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
+ Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
+ Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
+ Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
+ Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
It is also understood that an associate may receive special projects outside of this list.
DESIRED MINIMUM QUALIFICATIONS:
+ Minimum required education and experience: Bachelor's degree or equivalent with 8+ years of experience, Master degree with 5+ years of experience, Doctoral degree with 3+ years of experience
+ This position will require relevant experience working in manufacturing/operations.
+ In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
+ Experience with a proven track record of implementing appropriate risk mitigation.
+ Good technical understanding of manufacturing equipment and processes is required.
+ Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
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 (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
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 (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Source : Integra LifeSciences
