Quality Inspector III in Clearwater, Florida at Mercury Medical

DUTIES AND RESPONSIBILITIES:

* Perform receiving, in-process, and final inspection of raw materials, molded and extruded components, sub-assemblies, and finished devices per inspection instructions, control plans, drawings, and approved specifications.

* Take dimensional measurements using hand-held metrology, including calipers, micrometers, height and depth gauges, pin/plug gauges, thread gauges, and radius/feeler gauges.

* Operate an optical comparator and/or automated vision measurement system to verify dimensional, profile, and feature characteristics against drawing requirements.

* Perform functional and physical testing — including leak, pressure, flow, force/tensile, and pull/peel — per established test methods and acceptance criteria.

* Read and interpret engineering drawings and geometric dimensioning and tolerancing (GD&T) per ASME Y14.5 to determine inspection characteristics, datums, and tolerances.

* Apply documented sampling plans (e.g., ANSI/ASQ Z1.4) to determine sample size, inspection level, and accept/reject criteria.

* Verify that measuring and test equipment is within calibration prior to use; remove out-of-calibration or damaged instruments from service and notify the supervisor or metrology function.

* Record inspection and test data accurately and legibly in the QMS and Device History Record (DHR) in accordance with Good Documentation Practices.

* Mark, label, and segregate material as accepted, rejected, or on hold, and physically control nonconforming material.

* Initiate Nonconformance Reports (NCR) and route nonconforming product for Material Review Board (MRB) disposition, rework, or scrap as directed.

* Support First Article Inspection (FAI) and incoming qualification of new or changed components.

* Read work orders and travelers to verify part numbers, lot/serial identification, revision level, and applicable inspection requirements.

* Monitor in-process operations and assembly for conformance, and notify the supervisor of deviations from specifications, adverse trends, or equipment malfunctions.

* Maintain inspection areas, fixtures, and gauges in a clean, orderly, and calibrated condition.

* Support internal, external, and regulatory audits by retrieving records and demonstrating inspection and measurement methods.

* Follow all applicable GMP (21 CFR 820), ISO 13485, safety, and EHS requirements.

EDUCATION AND/OR EXPERIENCE:

* Minimum two (2) years of inspection experience in a regulated manufacturing environment (medical device, pharmaceutical, aerospace, or similar) required, or an equivalent combination of education and experience. Hands-on experience with dimensional metrology is required.

* ASQ Certified Quality Inspector or an equivalent metrology/inspection certificaiton is preferred.

* Working knowledge of GD&T (ASME Y14.5), sampling plans (ANSI/ASQ Z1.4), and Good Documentation Practices. Familiarity with medical device GMP (21 CFR 820) and ISO 13485 is preferred.

COMPUTER SKILLS:
Knowledge of ERP/MRP, electronic QMS (eQMS), spreadsheet, and word processing software. Familiarity with optical comparator or vision-system software is preferred.