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Senior Quality Engineer.US-WVF.002

Posted on Jan 14, 2022 by Integra LifeSciences

West Valley City, UT
Research
Immediate Start
Annual Salary
Full-Time
Overview:

Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.



 



Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we’ve evolved into one of the world’s leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.



But that’s just the beginning. Integra is growing at an unprecedented rate. We’re at a moment in time where the experience you’ll gain is more robust than the experience you bring. And we’re out to invest in your future because it’s the best way to maximize ours.



 



At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra’s ongoing commitment to our values and our shared success.



 



Integra’s health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both.



 



Regardless of geographic location, our commitment is to offer the following, whenever possible:



Benefit plans that meet all local statutory requirements



A range of programs that reflect typical local market practices



An opportunity for employees to tailor benefits to their specific needs



Benefits that balance employee’s short-term and long-term needs



Click for more information regarding our benefits and total rewards program



Responsibilities:

Active participant in the qualification and validation activities at IPM, including; cleaning validations, equipment qualifications, sterilization and stability validations, shipping validations and process validations.



Assist with the supplier management program including:Assist Purchasing, Operations, and Marketing with the supplier approval process.



Perform supplier site visits and periodic audits of critical suppliers.



Assists with Supplier Corrective Action system.



Provide technical assistance to marketing, customer service, regulatory, and operations.



Monitoring, maintaining and reporting associated with the Environmental Program, including; clean manufacturing environment monitoring for particulate and bioburden, vector control, quarterly product bioburden testing, and warehouse monitoring.



Investigate and trend customer complaints and trend repair histories of devices.



Assist in the developing inspection programs for products.



Assist in the creation of Purchasing and Product Specifications.



Investigate and trend product non-conformances



Perform other required tasks as needed.



Observes company’s safety policy and procedures at all times.



Gives and welcomes constructive feedback; contributes to building a positive team spirit.



Assists and leads lean initiatives.



Treats others with respect; works with integrity and ethically; upholds organizational values.



Qualifications:

Education: Bachelor’s Degree in an Engineering Discipline required.



 



Experience:Knowledge of FDA QSR and ISO Quality Standards.



Ability to analyze complex issues, conduct root cause investigations, and prepare reports on findings.



 



2 years minimum experience in the medical industry or similarly regulated industry.



 



Supportive Regulatory experience with a medical device manufacturer, preferred.



 



Strong skills in technical writing



 



Strong interpersonal skills and respect for confidentiality



 



Training as an Auditor, desired.



 


Reference: 61849466

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