Sr. Supplier Quality Engineer I
Sr. Supplier Quality Engineer I
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1 Vacancy
Job Description
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 whats 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 toassist 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
- Bachelors degree in engineering or Sciences with a minimum 5-years of experience in supplier quality management quality manufacturing or engineering OR a Masters 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.
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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. If you have difficulty using our online system due to a disability and need an accommodation please email us at
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Required Experience:
Senior IC
Employment Type
Full-Time
