Sr. Quality Engineer - Integra LifeSciences
Irvine, CA
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.
Sr. Quality Engineer is a direct contributor and owner of tasks within the Quality Management system. Including but not limited to: NCs/CAPAs/Complaint investigations, validation support, audit support etc.
The Senior Quality Engineer is responsible for implementation maintenance of the Rebound Therapeutics quality management system in accordance with 21 CFR Part 820, ISO 13485, MOD 93/42/EEC, ISO 14971. The Senior Quality
Engineer will assist in maintenance of the Quality Management System. The
Senior Quality Engineer may also assist during external audits from the FDA, FOB and Notified Body. The Senior Quality Engineer may also conduct vendor audits as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
* Initiates DCOs to update, correct and streamline documents in the QMS and for the manufacturing process.
* Suggests, implements projects to streamline product manufacturing and the QMS
* Works with QC to improve inspections, documentation. Develops workmanships standards for the product including development of Work Instructions (CWls).
* Works with suppliers on resolving non-conformances in raw material components, refining specifications, documentation, etc.
* Manages supplier files including approval, review, re-evaluation etc.
* Manages non-conforming material reports and makes suggestions for disposition, correction, corrective actions, verification of effectiveness, etc.
* Determines root cause for NCRs, CAPAs, complaints, product failures, etc.
* Manages CAPA system and makes suggestions for corrective actions, corrections, preventive actions, and effectiveness. Documents and closes CAPAs.
* Maintains calibration schedule and calibration of equipment. Controls calibration and manages non-conforming equipment.
* Reports on metrics related to the Quality Management System
* Initiates, investigates complaints from the company's products. Documents initiation, complaints, corrective action, if required. Manages complaint files. Performs decontamination of products. Handles returns on products.
* Updates risk management files
* Assists with sterilization configuration, sterilization documents, sterilization review, sterilization release
* Performs OHR review of documentation including label verification prior to final release of documentation
* May perform or assist in design, product, process, sterilization validations, etc.
* Other duties as assigned.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
+ Bachelors or Masters degree in Science, Engineering or related discipline
+ Five (5) years of related medical device industry experience is preferred.
+ Experience as Quality Engineer of start-up medical device companies.
+ Experience with initiating, implementing, and maintaining a Quality Management System in accordance with ISO 13485, 21 CFR Part 820, and MDSAP.
+ Experience with Notified Bodies, FDA, Competent Authorities, etc
+ Experience with deciding on substantial changes required notification to regulatory authorities.
+ Experience with eMDRs and Vigilance Reports
+ Experience with NCR and CAPA closure
+ Experience with internal and external audits.
TRAVEL REQUIREMENTS
Up to 5%
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.
Sr. Quality Engineer is a direct contributor and owner of tasks within the Quality Management system. Including but not limited to: NCs/CAPAs/Complaint investigations, validation support, audit support etc.
The Senior Quality Engineer is responsible for implementation maintenance of the Rebound Therapeutics quality management system in accordance with 21 CFR Part 820, ISO 13485, MOD 93/42/EEC, ISO 14971. The Senior Quality
Engineer will assist in maintenance of the Quality Management System. The
Senior Quality Engineer may also assist during external audits from the FDA, FOB and Notified Body. The Senior Quality Engineer may also conduct vendor audits as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
* Initiates DCOs to update, correct and streamline documents in the QMS and for the manufacturing process.
* Suggests, implements projects to streamline product manufacturing and the QMS
* Works with QC to improve inspections, documentation. Develops workmanships standards for the product including development of Work Instructions (CWls).
* Works with suppliers on resolving non-conformances in raw material components, refining specifications, documentation, etc.
* Manages supplier files including approval, review, re-evaluation etc.
* Manages non-conforming material reports and makes suggestions for disposition, correction, corrective actions, verification of effectiveness, etc.
* Determines root cause for NCRs, CAPAs, complaints, product failures, etc.
* Manages CAPA system and makes suggestions for corrective actions, corrections, preventive actions, and effectiveness. Documents and closes CAPAs.
* Maintains calibration schedule and calibration of equipment. Controls calibration and manages non-conforming equipment.
* Reports on metrics related to the Quality Management System
* Initiates, investigates complaints from the company's products. Documents initiation, complaints, corrective action, if required. Manages complaint files. Performs decontamination of products. Handles returns on products.
* Updates risk management files
* Assists with sterilization configuration, sterilization documents, sterilization review, sterilization release
* Performs OHR review of documentation including label verification prior to final release of documentation
* May perform or assist in design, product, process, sterilization validations, etc.
* Other duties as assigned.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
+ Bachelors or Masters degree in Science, Engineering or related discipline
+ Five (5) years of related medical device industry experience is preferred.
+ Experience as Quality Engineer of start-up medical device companies.
+ Experience with initiating, implementing, and maintaining a Quality Management System in accordance with ISO 13485, 21 CFR Part 820, and MDSAP.
+ Experience with Notified Bodies, FDA, Competent Authorities, etc
+ Experience with deciding on substantial changes required notification to regulatory authorities.
+ Experience with eMDRs and Vigilance Reports
+ Experience with NCR and CAPA closure
+ Experience with internal and external audits.
TRAVEL REQUIREMENTS
Up to 5%
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