Senior Quality Engineer
Senior Quality Engineer
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Salary Not Disclosed
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.
SUMMARY
The Senior Quality Engineer (SQE) is responsible for driving compliance with FDA 21 CFR 820 ISO 13485 and other applicable international regulations. This role will play a leadership role in NonConformity (NC) management CAPA investigations validation activities and risk management. The SQE will work crossfunctionally with manufacturing engineering regulatory and supply chain teams to ensure quality systems are effectively maintained and continuously improved. The SQE works independently with minimal supervision and leads projects and initiatives within the Quality Assurance department. This individual will provide guidance to and mentors junior engineers technicians quality staff and crossfunctional teams.
RESPONSINILITIES
To perform this job successfully an individual must be able to perform each essential duty satisfactorily:
NonConformities Management:
Lead the investigation root cause analysis and resolution of complex nonconformities (NCs) and Corrective and Preventive Actions (CAPAs).
Develop and implement corrective actions to prevent recurrence and ensure longterm compliance.
Trend and analyze quality data to identify systemic issues and drive improvements.
Training Management:
Support the development implementation and maintenance of the Training Management system.
Ensure training programs are uptodate compliant and aligned with Quality System requirements.
Monitor training completion and maintain training records for compliance purposes.
Supplier Management Activities:
Assist with supplier approvals audits and corrective actions as part of the Supplier Management program.
Validation and Qualification Activities:
Lead the investigation root cause analysis and resolution of complex nonconformities (NCs) and Corrective and Preventive Actions (CAPAs).
Develop and implement corrective actions to prevent recurrence and ensure longterm compliance.
Trend and analyze quality data to identify systemic issues and drive improvements.
Environmental Monitoring:
Support monitoring and reporting activities related to cleanroom environments vector control and product bioburden testing.
Risk Management & Regulatory Compliance
Ensure compliance with ISO 14971 by supporting risk management activities.
Maintain and enhance the Quality Management System (QMS) to align with ISO 13485 FDA 21 CFR 820 MDSAP and EU MDR.
Participate in external and internal audits supporting regulatory inspections and remediation efforts.
Additional Quality Support:
Investigate and trend customer complaints and product nonconformances.
Develop and maintain inspection programs for incoming inprocess and final products.
Provide technical assistance to crossfunctional teams including Marketing Operations and Regulatory.
Contribute to quality improvement initiatives and lean projects.
Other Duties:
Perform other duties as assigned by management.
QUALIFICATIONS
Education:
Bachelors degree in engineering or a related discipline required.
Advanced degrees (MS MBA) or certifications (CQE Six Sigma ASQ) preferred.
Experience:
Knowledge of FDA QSR and ISO Quality Standards.
5 years of experience in Quality Engineering within the medical device pharmaceutical or regulated industry.
Experience leading CAPA investigations and implementing effective corrective actions.
Strong experience with validation (IQ/OQ/PQ) and riskbased quality methodologies
Experience with Training Management systems and NonConformance processes is preferred.
Skills:
Strong problemsolving and root cause analysis skills 8D DMAIC Ishikawa etc..
Excellent communication and organizational skills.
Proficient in Microsoft Office Suite (Word Excel Outlook).
Strong attention to detail and ability to manage multiple tasks simultaneously.
Tools and Equipment Used
Standard office equipment: computers telephone and copy machines.
Quality tools: vernier calipers micrometers thread/plug gauges and optical comparators.
Physical Requirements
Ability to travel up to 10.
Frequent use of hands eyes and coordination to operate office and testing equipment.
Ability to lift and move objects up to 20 pounds occasionally.
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 youd like more information on your rights under the law please see the following notices:
EEO Is the Law EOE including Disability/Protected Veterans
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 or call us at.
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Required Experience:
Senior IC
Employment Type
Full-Time
