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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 systems. The successful candidate will be responsible for partnering with sterilization and microbiology Subject Matter Experts to assist in root cause investigations related to supplied services and/or processes, review and assess the accuracy and sustainability of supplier requirements as they pertain to sterility assurance and drive cross-functional collaboration with supplier quality groups across the organization.

This role requires a strong quality mindset, a willingness to learn about sterilization and microbiology, an understanding of medical device quality systems, and a commitment to ensuring product safety and compliance.

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

SUPERVISION RECEIVED

Under direct supervision of Sr. Quality Compliance Manager, Environmental Controls.

SUPERVISION EXERCISED

Indirect supervision of CMP QMS Workstream Team Members.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

Process Oversight:

+ Assist in root cause investigations related to supplied services and/or processes.

+ Review, assess, and update supplier requirements as they pertain to sterility assurance and microbiological endpoints.

+ Collaborate in the development of technical checklists and programs for supplier audits.

+ Drive integration of product sterility considerations into supplier quality processes.

+ Ensure compliance with industry standards such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements.

Cross-Functional Collaboration:

+ Work closely with sterility assurance and microbiology teams to ensure sterilization processes are integrated into the overall supplier quality process.

Regulatory Compliance & Documentation:

+ Ensure thorough documentation and records related to sterility assurance and microbiological endpoints as they pertain to supplier processes, including process flow diagrams, standard operating procedures, and program management tools.

+ Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.

DESIRED MINIMUM QUALIFICATIONS

+ Bachelor's degree in engineering, or Sciences with a minimum 5-years of experience in supplier quality management, quality, manufacturing, or engineering OR a Master's degree in a related discipline with 0-2 years of experience.

+ Demonstrates excellent organizational, verbal and written communication skills.

+ Proficient with the MS Office Suite, and statistical software.

+ Must be able to work independently with minimal supervision.

+ Able to prioritize projects and manage time to meet organizational goals and objectives.

+ Experience with External Regulatory Agency audits (i.e., Notified Bodies and FDA).

+ This position could require up to 25% travel.

Preferred Skills:

+ ISO 13485 Certified Auditor.

+ Experience using eQMS software solutions.

+ 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) | 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 [email protected].

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