Quality Inspector II

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Johnson & Johnson believes health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow.

Quality Control

Business Enablement/Support

Halethorpe, Maryland, United States of America

The Quality Inspector will perform inspections, checks, tests, and review of quality documents such as a device history report and sampling procedures of incoming materials, parts/components, partially assembled or finished medical devices. Provide support to Engineering and the Operations group as needed.

• Perform inspections of purchased parts, subassemblies or finished company product according to criteria using standard visual, physical, mechanical, and/or electrical measurements.
• Perform visual inspection on large lots of complex components under a microscope.
• Perform mechanical inspection using advanced inspection systems including vision or touch probe systems.
• Accurately document inspection and testing results to record components acceptance or rejection.
• Conduct and document process and system audits using written procedures as audit standards.
• Maintain all controlled document files and test records in a timely and accurate manner.
• Coordinate calibration of department test equipment and fixtures.
• Perform data entry into associated data systems; SAP knowledge preferred.
• Monitor critical equipment and instrumentation to ensure proper operation and calibration.
• Participate in construction and/or revising SOPs, inspection procedures, protocols, and checklists.
• Assist engineers in developing or improving inspection processes and checklists as problems or opportunities are identified.
• Identify and evaluate problems and make initial recommendations for possible corrective action to the supervisor.
• Communicate business‑related issues or opportunities to next management level.
• Follow all Company guidelines related to Health, Safety and Environmental practices.
• If supervising, ensure subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed are available and in good condition.
• Ensure personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
• Perform other duties assigned as needed.

• High School graduate or equivalent required. Associate Degree in a technical field preferred.
• 8+ years experience in quality inspection.
• Medical device experience preferred.

• Strong ability to perform complex mechanical inspection (may assist engineering with problem solving, fixture design, setups, and quality plans).
• Perform mechanical inspection using advanced systems including vision and touch probe.
• Perform electrical and optical cable and sensor testing.
• Extensive knowledge in Geometric Dimensioning & Tolerance.
• Extensive knowledge in IPC – 610.
• Ability to use all inspection gauges, electrical test equipment, and microscopes.
• Knowledge in ISO and GMP; US FDA 21 CFR QSR and ISO 13485.
• Attention to detail with the ability to follow SOPs and inspection procedures.
• Strong math and verbal/written communication skills.
• Knowledge of lean, six sigma, kaizen, and continuous improvement initiatives.
• Ability to lead and execute tasks in a timely manner with no supervision.
• Ability to lead and adapt to changing business needs and department priorities.
• Proficient in SAP desired and knowledge of Microsoft Office.

• The expected base pay range for this position is $21.63 - $34.00 per hour.
• The Company maintains highly competitive, performance‑based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
• This position is…