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QA

Company: Integra LifeSciences Holdings Corp.
Location: Billerica
Posted on: January 13, 2022

Job Description:

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 HERE for more information regarding our benefits and total rewards program

Responsibilities

SUMMARY DESCRIPTION

The Quality Control Technician will be responsible for performing quality inspections and testing according to established procedures. Inspection and testing activities will cover incoming, work-in-process, and finished goods. Assist in the daily operations of the Quality Control Laboratory

SUPERVISION RECEIVED

Manager or Director of Quality Assurance and Regulatory Affairs or Designated Quality Engineer

Oversee all functions and activities of the Quality Control Laboratory Area

Set priorities for departmental workloads and special requests

Maintain the calibration of all equipment and the calibration documentation system

General Inspection to Include:

o Mechanical testing of incoming components, WIP, finished devices, and repair/loaner devices using measuring equipment (i.e., micrometers, and calipers)

o Electrical testing of incoming components, WIP, finished devices, and repair/loaner devices using test equipment (i.e. Hipot tester and oscilloscope)

o Visual inspection, with or without magnification (i.e., microscope)

o Operating automated inspection equipment; namely the CMM and Optical Vision Systems

Accurate completion of inspection records to be retained at Integra Burlington as the Device History Records and documentation of all transactions using current MRP system.

Qualifications

Education: High School Graduate (or GED)

Experience 5-10 years in medical device or technologically related environment

Experience working within a formalized FDA or ISO quality system is required

Ability to follow established procedures, organization skills, and attention to detail are essential

Working knowledge of inspection equipment and blueprint reading (GD&T) preferred

Proficient with an MRP database

Strong knowledge of Good Manufacturing Practices and Good Laboratory Practice's

TOOLS AND EQUIPMENT USED

* CMM Measurement Equipment
* Optical Comparator
* Height Gage
* Various hand held measurement devices

Ability to utilize a computer, telephone, fax and copy machine as well as other general office equipment. Strong computer skills are required.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

DISCLAIMER

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.

Keywords: Integra LifeSciences Holdings Corp., Billerica , QA, Other , Billerica, Massachusetts

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