Quality Engineer II - Health Hazard Evaluation & Field Actions - Integra LifeSciences
Princeton, NJ
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 role is responsible for leading and executing Health Hazard Evaluations (HHEs) and supporting product Field Actions. This role will work cross functionally with all manufacturing sites, design assurance, medical affairs and other SMEs involved in the HHE process. Exposure and visibility to leadership on issues related to product quality, safety and/or performance is inherent with this role. A solid understanding of US and international regulations is required (21 CFR, MDSAP, EU MDR, etc.)
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Lead and coordinate all required activities, such as cross functional
meetings, to support the completion of HHEs.
* Ensure HHE documentation is complete, accurate and addresses regulatory requirements prior to approval.
* Prepare HHE documentation to be presented to Product Safety Board
that includes the Corporate VP of Quality, Corporate VP of Regulatory
and Corporate VP of Legal.
* Present HHE information at Product Safety Board alongside the other
SMEs.
* Continually monitor and provide routine metrics to management on the
progress of HHE's and Field Actions.
* When an HHE results in a Field Action, support the initiation of that
Field Action and any required logistics needed.
* Ensure Field Action documents are maintained and archived
appropriately.
* As needed, prepare documents required to be submitted to the FDA
for periodic updates and/or termination requests.
* Provide support and/or participate in regulatory audits/inspections as
required.
* Write and/or revise department procedures as needed.
* Keep apprised of new regulations, standards, policies, and guidance
documents issued by relevant regulatory authorities that may impact
HHE's and/or Field Actions. Perform all other related duties as directed
by management.
* Responsible for any changes or updates to the applicable Global
Operating Procedures and/or Templates.
* Participate in internal or external audits as the Subject Matter Expert
for HHEs.
* Participate in site or global projects and improvement efforts, as
needed.
* Keeps apprised of new regulations, standards and/or processes that
impact complaint handing and regulatory reporting responsibilities
* Other duties as assigned.
DESIRED MINIMUM QUALIFICATIONS:
* Education: Bachelor's degree in a scientific discipline required, preferably Biomedical Engineering; strong analytical skills, exceptional writing and interpersonal relationship skills.
* Experience: 3-5+ years' experience working in a medical device organization,
specifically in a Quality role.
* Computer skills to include knowledge and proficiency with Excel, SharePoint and proficient use of the worldwide web network.
* Strong writing, project management, problem solving, and communication skills.
* Experience working in Oracle, Agile and TrackWise systems preferred.
* Demonstrated organizational, management and communication skills.
* Must be able to observe company policies and safety procedures at all times.
* Must be able to give and welcome constructive feedback; contribute to building a positive team spirit.
* Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.
* Must be able to work independently with minimal supervision.
* Must be able to prioritize projects and manage time effectively
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 role is responsible for leading and executing Health Hazard Evaluations (HHEs) and supporting product Field Actions. This role will work cross functionally with all manufacturing sites, design assurance, medical affairs and other SMEs involved in the HHE process. Exposure and visibility to leadership on issues related to product quality, safety and/or performance is inherent with this role. A solid understanding of US and international regulations is required (21 CFR, MDSAP, EU MDR, etc.)
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Lead and coordinate all required activities, such as cross functional
meetings, to support the completion of HHEs.
* Ensure HHE documentation is complete, accurate and addresses regulatory requirements prior to approval.
* Prepare HHE documentation to be presented to Product Safety Board
that includes the Corporate VP of Quality, Corporate VP of Regulatory
and Corporate VP of Legal.
* Present HHE information at Product Safety Board alongside the other
SMEs.
* Continually monitor and provide routine metrics to management on the
progress of HHE's and Field Actions.
* When an HHE results in a Field Action, support the initiation of that
Field Action and any required logistics needed.
* Ensure Field Action documents are maintained and archived
appropriately.
* As needed, prepare documents required to be submitted to the FDA
for periodic updates and/or termination requests.
* Provide support and/or participate in regulatory audits/inspections as
required.
* Write and/or revise department procedures as needed.
* Keep apprised of new regulations, standards, policies, and guidance
documents issued by relevant regulatory authorities that may impact
HHE's and/or Field Actions. Perform all other related duties as directed
by management.
* Responsible for any changes or updates to the applicable Global
Operating Procedures and/or Templates.
* Participate in internal or external audits as the Subject Matter Expert
for HHEs.
* Participate in site or global projects and improvement efforts, as
needed.
* Keeps apprised of new regulations, standards and/or processes that
impact complaint handing and regulatory reporting responsibilities
* Other duties as assigned.
DESIRED MINIMUM QUALIFICATIONS:
* Education: Bachelor's degree in a scientific discipline required, preferably Biomedical Engineering; strong analytical skills, exceptional writing and interpersonal relationship skills.
* Experience: 3-5+ years' experience working in a medical device organization,
specifically in a Quality role.
* Computer skills to include knowledge and proficiency with Excel, SharePoint and proficient use of the worldwide web network.
* Strong writing, project management, problem solving, and communication skills.
* Experience working in Oracle, Agile and TrackWise systems preferred.
* Demonstrated organizational, management and communication skills.
* Must be able to observe company policies and safety procedures at all times.
* Must be able to give and welcome constructive feedback; contribute to building a positive team spirit.
* Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.
* Must be able to work independently with minimal supervision.
* Must be able to prioritize projects and manage time effectively
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
