Quality Inspector II

Integra LifeSciences is a global medical technology leader in neurosurgery and regenerative medicine driven by our purpose of restoring patients’ lives. The company offers a broad portfolio of products and innovative solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. Its regenerative tissue technologies include products that address soft tissue, peripheral nerve and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery.

Founded in 1989 by Richard E. Caruso, the company is headquartered in Princeton, New Jersey. Today, Integra LifeSciences has grown immensely, with more than 4200 employees worldwide as well as offices, manufacturing and research facilities in Asia, Australia, Europe, Middle East, and the Americas.

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 what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Quality Inspector is responsible for completing inspections of raw materials, purchased components, work in process, and finished goods prior to release for distribution at Integra LifeSciences, Cincinnati, Ohio.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

Primary responsibilities are to:

• Perform all required quality inspections according to inspection instructions and/or product drawings.
• Utilize department databases to track and manage inspection workload and rejected products.
• Adhere to SOPs, policies, and ISO/QSR requirements.
• Complete archival activities for device history records for inspected lots.
• Write and process Material Reject Reports as necessary.
• Manage inventory on hold for quality inspection.
• Review and update inspection plans as needed.
• Handle transactional duties for incoming, work-in-process, and finished goods processing in the designated product line.
• Cross-train in two or more product lines.

Note: Other duties may be assigned as necessary.

DESIRED MINIMUM QUALIFICATIONS

Education & Experience :

• High School or Trade School Graduate (or GED) minimum is required.
• 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 is required
• Ability to interpret instructions, blueprints, and drawings to effectively inspect product is required.
• Ability to utilize multiple gauges and measurement tools for inspection of manufactured components and assemblies is required.
• Use of math skills relative to physical measurement of product (calculations involving basic functions and metric units) is required.
• 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, and Excel

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 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.

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 workstation, with some required standing and walking during the course of the day. Persons must have good vision, corrected or otherwise.

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.

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 you'd 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 [email protected].

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 candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.