Senior Supplier Quality Engineer I - Integra LifeSciences
Boston, MA
About the Job
Changing lives. Building Careers.
Joining us is a chance 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, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
This position is for a Sr. Supplier Quality Engineer l - Global Supplier Quality with hands-on experience and proven success in managing Supplier Quality system while supporting and leading strategic initiatives to build a robust supplier quality system for the organization.
The ideal candidate should demonstrate proficient experience with quality management concepts including but not limited to supplier quality audits, eQMS, risk assessment, process qualification, process controls, root cause investigations, CAPA, and continuous improvement​
+ Provide support to sites by leading critical Supplier Quality related projects and issues which may require supplier visits and audits.
+ Coordinate and facilitate periodic quality reviews and support business reviews with key suppliers
+ Work with suppliers to resolve quality related issues by issuing and monitoring SCARs.
+ Drive continuous improvement in with supplier based on the established criteria and metrics.
+ Build relationships with internal and external partners and influence external manufacturers to continuously improve processes and procedures.
+ Participate in Quality Management Reviews and monthly Quality Forums
+ Collect and analyze performance data against defined parameters.
+ Lead the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans.
+ Support the integration of newly acquired businesses.
+ Integrate/participate in the overall quality/operation/division leadership community by sharing and seeking best practices and methodologies and finding new ways to help drive for maximizing performance.
+ Implement and sustain continuous improvement practices and culture throughout the organization.
+ Provides strategic direction and communication of the company's goals, directives, and policies to subordinates, creating a clear vision and positive, team-oriented environment resulting in the achievement of the company's goals and increased profitability.
+ Direct the activities of the GSQ department to ensure compliance with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, MDR, JPAL and 21 CFR Part 11
+ Interact and coordinate activities with other departments, external vendors, and customers. Influences and collaborates across stakeholder groups in the areas of process / continuous improvements, identify and implement opportunities.
Qualifications
+ Master's degree in engineering, or Sciences.
+ Minimum 7-years of experience in supplier quality management, quality, manufacturing, or engineering.
+ Experience in FDA controlled environment.
+ Strong collaboration skills and experience working in a matrix environment.
+ Ability to read and understand technical and statistical documents.
+ Ability to interface with tech
+ Technical and non-technical personnel.
+ Travel up to 30%
+ ISO 13485 Certified Auditor preferred.
+ Experience using eQMS software solutions preferred.
+ Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards.
+ Experience using analytical tools to drive data-based decision making.
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 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, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
This position is for a Sr. Supplier Quality Engineer l - Global Supplier Quality with hands-on experience and proven success in managing Supplier Quality system while supporting and leading strategic initiatives to build a robust supplier quality system for the organization.
The ideal candidate should demonstrate proficient experience with quality management concepts including but not limited to supplier quality audits, eQMS, risk assessment, process qualification, process controls, root cause investigations, CAPA, and continuous improvement​
+ Provide support to sites by leading critical Supplier Quality related projects and issues which may require supplier visits and audits.
+ Coordinate and facilitate periodic quality reviews and support business reviews with key suppliers
+ Work with suppliers to resolve quality related issues by issuing and monitoring SCARs.
+ Drive continuous improvement in with supplier based on the established criteria and metrics.
+ Build relationships with internal and external partners and influence external manufacturers to continuously improve processes and procedures.
+ Participate in Quality Management Reviews and monthly Quality Forums
+ Collect and analyze performance data against defined parameters.
+ Lead the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans.
+ Support the integration of newly acquired businesses.
+ Integrate/participate in the overall quality/operation/division leadership community by sharing and seeking best practices and methodologies and finding new ways to help drive for maximizing performance.
+ Implement and sustain continuous improvement practices and culture throughout the organization.
+ Provides strategic direction and communication of the company's goals, directives, and policies to subordinates, creating a clear vision and positive, team-oriented environment resulting in the achievement of the company's goals and increased profitability.
+ Direct the activities of the GSQ department to ensure compliance with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, MDR, JPAL and 21 CFR Part 11
+ Interact and coordinate activities with other departments, external vendors, and customers. Influences and collaborates across stakeholder groups in the areas of process / continuous improvements, identify and implement opportunities.
Qualifications
+ Master's degree in engineering, or Sciences.
+ Minimum 7-years of experience in supplier quality management, quality, manufacturing, or engineering.
+ Experience in FDA controlled environment.
+ Strong collaboration skills and experience working in a matrix environment.
+ Ability to read and understand technical and statistical documents.
+ Ability to interface with tech
+ Technical and non-technical personnel.
+ Travel up to 30%
+ ISO 13485 Certified Auditor preferred.
+ Experience using eQMS software solutions preferred.
+ Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards.
+ Experience using analytical tools to drive data-based decision making.
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