Document Review Inspector II, Quality- 2nd shift in Mahwah, NJ at Stryker Corporation

Date Posted: 9/30/2020

Job Snapshot

Job Description

General Description

Under general supervision, the Quality Inspector will perform DHR review and final release of Medical Devices at Stryker, ensuring product quality and throughput goals are met. Ensure compliance to procedures and practices at all times.

Essential duties & responsibilities:

Working within the Inspection Team, the Quality Inspector is responsible for documentation review and inspection related activities.  Responsibilities include but are not limited to the following:

•             Perform Document Review, analyze, inspect and archive DHRs (paper-based and/or electronically) in compliance to GMP/GDP requirements prior to release to finished goods for manufactured and dock-to-stock products.

•             Perform computer system transactions related to router inspections, etc.

•             Segregate, quarantine and complete documentation for non-conforming materials when necessary.

•             Initiation of quarantine tickets (non-conformance reports)

•             Perform product release disposition tasks in the ERP system

•             Support the achievement of Inspection Teams’ KPI's.

•             Work to forecasts and plans based on Business requirements.

•             Perform dimensional and/or visual inspection to blueprint and Inspection Guide Sheets using gauges and other reliant inspection equipment when necessary.

•             Perform material and component inspections when necessary.

Qualifications & Experience required:

4+ years of product inspection experience in a cGMP manufacturing environment.

2+ years of technical education preferable.

Ability to read blueprints and specifications exhibited.

Moderate proficiency in the use of all standard inspection equipment including calipers, micrometers, etc.

Proficiency in the use of coordinate measuring machines, electrical / visual inspection techniques may also be required.

Proficiency in understanding of Inspection Sampling Plans

Excellent attention to detail.

Basic understanding of mathematical concepts

Ability to build proficiency in GD&T

Demonstrated computer skills including basic proficiency in MS Outlook and MS Office Suite

Demonstrated communication and interpersonal skills and the ability to work in a team-based environment that heavily emphasizes quality, safety, performance, cross-training, customer service and accountability

Ability to build basic proficiency of FDA CFR 820 and ISO 13485 Regulations

Demonstrated flexibility and team player.

Good timekeeping, attendance and performance track record

Preferred ability to lift up to 25 pounds on an occasional basis

High School Diploma or equivalent.

Vocational/technical school training/certificate

Formal GD&T training (Geometric Dimensioning and Tolerancing), also preferable.

Work From Home: Not available

Travel Percentage: 0%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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