Responsible for the inspection and disposition of incoming components, finished products, and packaging/labeling products operations. Disseminates information and provides reports regarding the inspection and test status of product in QC to various departments.
- Follows directions from the Supervisor, Quality Control Technicians prioritizing daily inspection activities for the department.
- Participates in special projects such as first article inspections, measurement analysis, fit to mating part analysis, design verification testing, and gage repeatability studies.
- Identifies, documents, evaluates, and initiates Nonconforming Material Reports (NCMRs) for resolution.
- Inspects and audits in-house packaging, labeling and assembly operations including approving line labeling clearance for the packaging department
- Inspects medical devices to established standard operating procedures and product specifications.
- Complies with all relevant SOP’s and Work Instructions and properly documents activities when necessary.
- Assists in the establishment of quality control specifications and revises existing specifications to support new product introductions.
- Performs daily mainframe computer transactions.
- Reviews and evaluates statistical sampling plans to ensure that sampling plans are adequate based on upon complaints and nonconforming material.
- Works on special projects as assigned.
Requires moderate understanding of general job aspects and superficial understanding of the technical phases of the job.
- Requires a BA/BS in a related field, or equivalent experience.
- Requires minimum of 2 years Quality Control or related experience.
- Must have understanding of Good Manufacturing Practice (GMP).
- Must have strong PC skills
- Must be able to use general inspection equipment including micrometer, caliper, pin/block gages, power supply, scales
- Must be detail-oriented with excellent interpersonal communication skills.
- Must be willing to follow strict FDA guidelines.
- This position requires the handling of instruments that may have been contaminated by blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.
Close supervision involving detailed instructions and constant checking on work performance.
LANGUAGE AND MATHEMATICAL SKILLS; REASONING ABILITY:
Language Skill: Ability to read and interpret documents such as safety rules, operating
and maintenance instructions, and procedure manuals.
Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals.
Reasoning Ability: Ability to understand and use sampling tables such as ANSI Z1.4 in routine applications.
PHYSICAL REQUIREMENTS/PHYSICAL ACTIVITIES:
- Medium Work: Position involves ability to frequently or constantly exert up to 20 pounds of force and occasionally exert up to 50 pounds of force to move objects.
- 21 CFR Part 820, Quality System Regulation
- Aesculap Training Matrix
- Bloodborne Pathogen Training
- International Quality System Standards - ISO9001/ EN46001/ ISO13485
- Measurement Technique Analysis
- ANSI/ASQC Z1.4, Statistical Sampling Plan Overview
- SAP QC Inspection Modules/ Material Master Modules
- Microsoft Word, Excel, and Access
B. Braun Medical Inc. - 21 months ago
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