Quality Engineer II
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 4000 of us are challenging whats possible and making headway to help improve outcomes.
The Quality Engineer II oversees the execution of the quality plans ensuring product realization is conducted in compliance with internal customer and regulatory requirements during all phases of the product lifecycle. Under limited supervision and in accordance with all applicable federal state and local laws/regulations procedures and guidelines this position:
This role will be based in Haifa following our planned office relocation in 2026.
Reviews new and modified product design and manufacturing processes for quality characteristics including manufacturability serviceability testability reliability and conformance to product and quality system requirements.
Develops and manages the product risk management process including the development and maintenance of risk management files.
Qualifies component and service suppliers conducts supplier audits and ensures that appropriate supplier quality controls are implemented.
Analyzes data and applies knowledge of engineering principles and practices to implement continuous improvement projects.
Provides guidance to R&D Operations and Quality on design and production/process controls risk management root cause analysis validation and the application of statistical methods.
Host business meetings with other functions within the organization including but not limited to Training Human Resources Manufacturing and Research and Development.
May manage projects that involve other functions within the organization including but not limited to Training Human Resources Manufacturing and Research and Development.
Responsible for communicating business related issues or opportunities to the next management level.
Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.
For those who supervise or manage staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable.
Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures.
Performs other duties assigned as needed.
Qualifications:
Bachelors degree in life science engineering physical science or related field
At least 3 years of experience as a quality professional in an FDA-regulated industry with at least 1 years in the medical device industry
In-depth knowledge of design control risk management production and process controls and applicable regulations (i.e. ISO 13485 FDA Quality System Regulation ISO 14971)
Working knowledge of and experience in the application of statistical methods
Fluent in Hebrew and English
Excellent verbal and written communication skills
Preferred:
Advanced degree in life science engineering physical science or related field
Process Excellence/Six Sigma certification
Knowledge of design control risk management production and process controls and applicable laws (i.e. ISO 13485 FDA Quality System Regulation ISO 14971)
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency and it must be executed and authorized by the Vice President Talent Acquisition. Where agency agreements are in place introductions (the initial sharing of a candidates name resume or background) are position-specific and may only occur within the scope of that approved agreement. Please no phone calls or emails.
Required Experience:
IC
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
Integra LifeSciences, a world leader in medical technology with headquarters in Princeton, New Jersey, was founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue. Since then, Integra has expanded its base regenerative te ... View more
