Summary of Position with General Responsibilities:|
Summary of Position with General Responsibilities:
Under the general supervision of the Quality Manager, lead inspectors to perform electrical, mechanical, and visual inspections on finished goods, in-process products, and incoming raw materials used in the production of products according to documented test and inspection methods.
Essential Job Functions:
Coordinate all Quality Control activities to ensure that production plans and objectives are completed. Schedule priorities; assign inspection activities and coordinate with other departments to prioritize inspections as appropriate.
Assist with resolving quality problems within inspection department, such as documentation or non-compliance issues
Assist in organizing the Non-Conforming Material and Material Review Board processes.
Perform QC Incoming, In-Process, First Article, and Final Inspections following written procedures
Perform inspections utilizing automated and semi-automated optical inspection equipment and/or coordinate measurement machines (CMMs).
Perform visual inspections utilizing microscopes, loupes, tappi charts, and surface finish standards
Complete and file quality records including process travelers, inspection reports, and non-conforming material reports.
Review completed process travelers for accuracy and completeness and perform product documentation final release reviews
Provide cross training for all tasks in the Incoming Q.C. department; ensure that department/ employee training records are accurate and complete.
Assist in the establishment, measure, tracking, and trending of quality metrics and objectives
Assist in monitoring supplier quality. Perform data entry and generate monthly supplier reports.
Assist in the development of QC Inspection Processes, procedures, documentation, and fixtures
Maintain the Quality Control Inspection area in a neat and orderly manner
The ability to work overtime
Essential Job Functions:
Ensure calibrations and maintenance are performed on department equipment; determine new equipment requirements and needs.
Assist Engineering as required to perform process and product validation testing
Assist Engineering and Quality Assurance to perform component validation and characterization testing
Perform, or assist in performing Internal Audits of Quality Management System processes
Assist in reviewing Engineering Change Orders for completeness, accuracy, and conformance with requirements.
Assist in performing transfers of product inspection, test, and manufacturing processes from external organizations to Dymax
Assist in Failure Analysis and Complaint Investigations of non-conforming field returns
Support the Returned Material process and perform related product assessments and inspections
Other duties as required.
Duties require knowledge of inspection/sampling techniques and familiarity with ANSI/ASQ Z1.4
Strong familiarity with FDA QSR and ISO 13485 Quality System Requirements
Knowledge of IPC 610 Standards PC Assembly Workmanship
Knowledge of electronics assembly and test
Knowledge of auditing to FDA QSR and ISO 13485 Quality System Requirements
Detailed knowledge of mechanical and physical inspection techniques (calipers, micrometers, depth gauges, blueprint reading, CMM or optical comparator, burst test, seal strength, etc.)
Good oral and written communication skills, Ability to communicate well with technical personnel
Strong familiarity with computer applications such as Microsoft Outlook, Excel and Word
Demonstrated strong attention to detail and “do it right the first time” attitude
Additional Desirable Qualifications Skills and Knowledge:
ASQ Certification Preferred
Duties require basic knowledge of math and physics equivalent to completion of two years of college; 2 Year Associates degree in electronics preferred.
At least five years experience doing inspection within a FDA regulated environment.
1-2 years experience in leading QC staff
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...