- 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.
- Expectation to know transactional duties for incoming, work in process, and finished goods processing in designated product line.
- Expectation to be cross trained in two (2) or more product lines.
- Expected to train other colleagues in product lines of expertise.
- 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, blueprints, 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.
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Quality Inspector II, 2nd Shift - Cincinnati, United States - Integra LifeSciences
Description
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 4,000 of us are challenging what's possible and making headway to help improve outcomes.
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.
Primary responsibilities are to:
MINIMUM QUALIFICATIONS
Education & Experience :
TOOLS AND EQUIPMENT USED
Daily use of measurement tools such as calipers, micrometers, optical comparator and gage pins/blocks. 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 workstation, with some required standing and walking during the course of the day.
SELECTION GUIDELINES
Formal application, rating of education and experience; oral interview and reference check; job- related tests may be required.
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 or call us at
Integra - Employer Branding from Integra LifeSciences on Vimeo )
