Quality Inspector

Our Client is looking for Quality Inspector- With good experience in Quality, Inspections, documentations, guidelines etc. experience…..!!!!!

SUMMARY & RESPONSIBILITIES:

• 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

QUALIFICATIONS AND SKILLS NEEDED:

• A bachelor’s degree or Master’s degree in Science or with 1-5 years of experience in a pharmaceutical/biotechnology industry.

• Minimum 3 years of experience in Quality Inspection (or minimum 6 Yrs 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. Working knowledge of GD&T preferred.

• Ability to utilize multiple gauges and measurement tools for inspection of manufactured components and assemblies.

• Previous experience with CMM and/or Vision System operation is a plus.

• 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.

• Some overtime may be done

Regards

Pooja Mishra

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I

Tel: 732 429 1636

(W) 732-549-2030 x 214 | (F) 732-549-5549

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