Quality Inspector II

Company: Integra LifeSciences
Location: Cincinnati
Posted on: July 23, 2021

Job Description:

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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.

• Completes all required quality inspections following inspection instructions and/or product drawings. Use department databases to track and manage inspection workload and rejected products. Effectively follow SOPs, policies and ISO/QSR requirements.
• Completes archival activities for device history records for lots inspected.
• Writes and processes Material Reject Reports, as necessary, and manage inventory that is on hold for quality inspection.
• Reviews and updates inspection plans, as needed. Write DCO’s (Engineering Change Requests) to update as required. Assist Operations personnel in maintenance and updating of other Device Master Record documentation.  
• Provides support for the Quality System during corporate audits, actively participate in department activities and Perform audits of operations areas to confirm compliance with controlled procedures, as required.

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

Education & Experience:

• High School or Trade School Graduate (or GED) minimum.
• Certified Quality Technician (ASQ CQT) would be a plus.
• Minimum three (3) years of experience in Quality Inspection (or minimum six (6) years in a manufacturing environment where responsible for measurement of products) and preferably in an FDA regulated environment.
• Ability to interpret instructions and drawings to effectively inspect product.
• Ability to utilize multiple gauges and measurement tools for inspection of manufactured components and assemblies.
• Use of math skills relative to physical measurement of product (calculations involving basic functions and some geometry/trigonometry in English and metric units).
• Knowledge of ISO, FDA and QSR concepts and guidelines preferred.
• Excellent communication and organizational skills.
• Outstanding attention to detail.
• Strong interpersonal skills and ability to work with others in a positive and collaborative manner.
• Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
• Knowledge of various MS Office applications such as: Word, Excel, and Access.

TOOLS AND EQUIPMENT USED

Daily use of measurement tools such as calipers, micrometers, optical comparator and gage pins/blocks. 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 position will require persons to lift product or boxes of product from floor level to chest level. Most work is done in elevated seating position at a work station, with some required standing and walking during the course of the day. Persons must have good vision, corrected or otherwise.

The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required 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.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility. Must be capable of using a keyboard for computer purposes.

Keywords: Integra LifeSciences, Cincinnati , Quality Inspector II, Other , Cincinnati, Ohio