With limited supervision performs quality inspections for IAB-C. Assists the QC Supervisor, QA Engineer and/or Quality Manager in the required areas as listed in Principal Responsibilities.
Principal Responsibilities• Compliance to all work instructions, Quality regulations, SOP’s, WI’s, GMP’s and GDP’s in the effort to manufacture high quality medical devices at all times.
• Training: As required, will train employees to inspection requirements and techniques in manufacturing or other areas.
• Retrieval of documentation or work instructions through Agile as necessary, to perform inspections.
• Reviews orders and job packets, recording batch numbers and quantities, as required by inventory system.
• Communication: shares instructions and knowledge with other inspectors or employees within the quality department.
• Records results in a legible and accurate manner.
• Reads, interprets and applies dimensional or other requirements defined in work instructions, process documents or graphics.
• Provides support for special projects and assignments, including work in areas such as validations, nonconformance investigations and CAPAs.
• Serves on and is actively involved in cross-functional teams. Interface, when needed, with various levels of manufacturing or engineering regarding quality issues.
• Uses required tools and instruments (i.e. caliper, plug gauges, multimeter, microscope, and micrometer) to measure, assess or analyze quality attributes.
• Inspect IAB and RH sub-assemblies and assemblies for cosmetic and physical flaws and/or perform electrical, mechanical and visual inspections of sub-assemblies and final assemblies.
• Support in process and Final Inspection.
• Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all company policies, rules, procedures and housekeeping standards.
• High School Diploma/GED
Specialized Skills / Other Requirements• Minimum of six months of quality experience, preferably in medical device.
• Experience with Quality Management Systems (ISO 13485 and Medical Device Regulations (21 CFR 820).
• Must possess Quality job knowledge, including inspection, testing and record keeping.
• Must be proficient in basic computer skills, Microsoft Office and SAP experience preferred.
• Excellent Communication Skills
• Must be extremely detail-oriented.