Position Type:

Direct Hire Shift/Hours:

1st shift

Location:

Vernon Hills, IL Responsible for ensuring that products meet established quality standards and specifications prior to being released to customers. Performs incoming, in-process, and final inspection of components, sub-assemblies, and finished goods.

REQUIREMENTS AND RESPONSIBILITIES

Performs inspection activities per procedures to ensure product and process conformance. Uses measuring and testing devices such as calipers, micrometers, gauges and comparators to measure dimensions in metric. Accurately records results of inspections and maintains inspection logs. Performs data entry and queries in SAP. Ensures compliance with all applicable regulatory requirements for medical devices such as 21CFR820 and

ISO 13485.

Reviews Certificate of Analysis and Conformance or other submitted quality data to ensure compliance with specifications. Escalates awareness of patterns of product failures or process deviations to proactively reduce process errors and improve regulatory compliance. Completes Nonconforming Device or Process reports and executes containment actions. Perform and/or participates in corrective & preventative action (CAPA) investigation, as needed. Safeguards measuring and test equipment and performs maintenance activities as required. Participates in developing inspection procedures and work instructions. Promotes and models RWMIC Core Values in all interactions and responsibilities.

ADDITIONAL RESPONSIBILITIES

Complies with regulatory requirements using Good Documentation Practices (GDP). Ensures training status is current for applicable procedures prior to execution of duties. Supports any quality related activities as required by the Quality Control Manager. Completes non-conformance reports and execute containment actions as needed. Aware of and complies with the RWMIC Quality Manual and regulations & requirements as they apply to this job type/position. Completes all planned Quality & Compliance training within the defined deadlines. Other duties as assigned by the Quality Control Manager.

QUALIFICATIONS

High school diploma or equivalent with preference for vocational studies, such as machine shop, or computerized mechanical drawings preferred. 1-3 years' experience in a quality control or quality assurance role in the medical device industry preferred. Experience in a medical device manufacturing environment operating under regulations such as 21CFR820, ISO 13485, etc. preferred. Strong verbal and written skills communications skills. Strong attention to detail and ability to accurately identify defects or deviations from quality specifications. Basic SAP capability to data entry and queries. Ability to learn RWMIC product information. Ability to perform all types of QC inspection functions. Proficient in the usage of a variety of measuring and test equipment including but not limited to micrometers, calipers, surface-tester, rulers, gauge blocks, optical and digital comparator, automated measuring equipment, electrical instruments and various hand tools. Intermediate PC skills and familiarity with all MS Office suite products. Ability to complete quality documents accurately. Ability to work independently with minimal supervision and collaborate effectively within a team environment. Flexibility to work different shifts or overtime as needed to support production schedules and meet quality objectives. Experience with and understanding of multi-cultural and multi-generational differences and the ability to work within this environment is crucial for successful employment. The following physical demands are required: Lift/Carry up to 20 pounds Stand/Sit/Walk 8 hours per day RWMIC offers Immunizations for Hep B and Flu Shots to all RWMIC employees. RWMIC employees have the responsibility to themselves and the company to consider receiving these immunizations. All RWMIC Employees have the responsibility to themselves and the company to work safely. WORK@WOLF We are proud to offer a competitive pay structure along with a well-rounded benefits package designed to support our employees' career growth, health, and work-life balance.

Our benefits include:

401(k) Retirement Savings Plan with Company Match Medical, Dental, and Vision Coverage Company-Paid Life & Disability Insurance Paid Time Off and Paid Parental Leave Flexible Work Options - Telecommuting and Flexible Schedules Tuition Reimbursement for Continuing Education Wellness Program and Flexible Spending Accounts (FSAs) At Richard Wolf, we believe in creating a workplace where everyone has the opportunity to thrive. We are committed to providing equal employment opportunities to all individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, status as a protected veteran, or any other legally protected status. 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