Job Description

Position Purpose: Perform inspection of incoming components and raw materials ensuring compliance with internal and customers established standards.

KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:

· Responsible for the incoming inspection of raw materials, components and packaging utilized in medical device

manufacturing, to determine conformance to approved specification and test requirements.

· Read and interpret part drawings, have basic mathematical skills and utilization of measuring instruments.

· Ability to follow test procedures, perform visual inspections, identify variations against standards, colors and textures.

· Collect or select samples for testing, evaluation or as retain samples.

· Perform incoming inspection documentation review and approval to ensure compliance to procedures and good

documentation practices.

· Confirm material/component identification and complete functional testing of product.

· Read and interpret part drawling, data, manuals, and other materials to determine specifications, inspection and

testing procedures, and measuring instruments required for inspection.

· Initiate rejection for nonconforming materials, which do not meet specifications.

· Initiate or assist Supplier Quality Manager in creating SCAR for rejected supplier related materials as required.

· Discuss visual and dimensional inspection results with Supply Chain personnel and provide supporting information in a

timely manner.

· Initiate hold status and or rejection in SAP for nonconforming materials, which do not meet specifications.

· Provide documentation, samples and test results to Supplier Quality Manager for nonconformances/ SCAR events .

· Maintain, review, and approve records, documentation and retain samples per procedural guidelines.

· Discuss visual and dimensional inspection results with other department personnel and provide supporting

information in a timely manner to assist in final product disposition.

· Assists Supplier Quality Manager and production Quality Managers in coordinating and executing objectives

throughout the company in cooperation with other employees, to maximize product quality and operating system

efficiency/effectiveness to minimize costs.

· Support and comply with all policies of the company including but not limited to cGMP, ISO Standards, Health and

Safety Requirements and Continuous Improvement as well as standard work procedures.

· Perform identification and functional testing of product.

· Generate labels to identify material of acceptance, hold or rejection status.

· Notify Supplier Quality Manager, Buyer/Planner, and other appropriate personnel by email communication when

nonconformances are identified.

· Ensure calibration status of instruments in IQA lab is current prior to use and is meeting predetermined

requirements. Awareness to notify Metrology department if service or calibration is required.

· Other duties as assigned.

POSITION REQUIREMENTS:

· Associate degree is preferred. Minimum 3 years of work experience in a quality control function.

· Able to read and comprehend specifications, schematic drawing procedure and related forms of information in

English.

· Strong attention to detail, problem solving skills and responsible decision making.

· Experience in an ISO 9001 work environment a plus.

· Able to lift up to 35 lbs.

PREFERRED KNOWLEDGE/SKILLS:

· Basic computer skills. Word, Excel, PowerPoint and corporate network navigation.

· Ability to read and interpret simple mechanical drawings, schematics and follow laboratory test instructions.

· SAP experience desired.

WORK ENVIRONMENT:

· Office, warehouse and clean room environments that may include moderate noise levels and required appropriate PPE and cleanroom apparel as necessary.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries. With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors.

We put patients first when creating drug delivery devices because we know that accurate dosing and ergonomics contribute to patients completing their treatment. Working at Nemera means being part of a team that truly enjoys working together and always goes the extra mile to deliver on its commitments. We’re proud of the work we do because it improves patients’ lives.

Nemera is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other protected class indication. This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.

The Nemera timekeeping system utilizes finger scan. Our biometric policy is available upon request at bghr@nemera.net

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