Sr. Quality Engineer - Global Supplier Quality - Integra LifeSciences
Columbia, MD
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.
This position is for a Sr. Quality Engineer - 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 Sr. SQE will support and lead strategic initiatives to build a system and culture resulting in year-on-year quality/process improvements. The ideal candidate should demonstrate proficient experience with quality management concepts and Project Management including but not limited to supplier quality, eQMS, risk assessment, process qualification, process controls, root cause investigations, CAPA, and continuous improvement.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
+ Lead and support GSQ leadership in driving digital transformation strategy to implement eQMS for managing Global Supplier Quality activities.
+ Provide support to sites by leading critical Supplier Quality related projects and issues which may require supplier visits and audits.
+ Develop and implement visual (real-time) metrics and reporting to drive continuous improvement in the GSQ group.Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.
+ Develop procedures and train employees on using digital technology for Supplier Quality related activities.
+ Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
+ 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 or Bachelors Degree in Engineering, Computer Science or Sciences.
+ Minimum 7-years of experience in quality, manufacturing, or engineering.
+ Strong experience using or supporting the implementation of eQMS software solutions preferred.
+ Project Management experience preferred
+ 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 technical and non-technical personnel.
+ Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards.
+ Experience using analytical tools to drive data-based decision making.
+ 25% travel required.
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.
This position is for a Sr. Quality Engineer - 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 Sr. SQE will support and lead strategic initiatives to build a system and culture resulting in year-on-year quality/process improvements. The ideal candidate should demonstrate proficient experience with quality management concepts and Project Management including but not limited to supplier quality, eQMS, risk assessment, process qualification, process controls, root cause investigations, CAPA, and continuous improvement.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
+ Lead and support GSQ leadership in driving digital transformation strategy to implement eQMS for managing Global Supplier Quality activities.
+ Provide support to sites by leading critical Supplier Quality related projects and issues which may require supplier visits and audits.
+ Develop and implement visual (real-time) metrics and reporting to drive continuous improvement in the GSQ group.Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.
+ Develop procedures and train employees on using digital technology for Supplier Quality related activities.
+ Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
+ 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 or Bachelors Degree in Engineering, Computer Science or Sciences.
+ Minimum 7-years of experience in quality, manufacturing, or engineering.
+ Strong experience using or supporting the implementation of eQMS software solutions preferred.
+ Project Management experience preferred
+ 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 technical and non-technical personnel.
+ Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards.
+ Experience using analytical tools to drive data-based decision making.
+ 25% travel required.
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