Omnicell Warrendale , PA 15086
Posted 3 weeks ago
Job Summary
Omnicell is excited to be seeking an experienced Sr. Quality Technician t to join our Quality Operations department. The Sr. Quality Technician will be supporting Production & Supplier Quality teams, in addition to performing inspection activities. This role will be based in Warrendale, PA.
Responsibilities
Provide and document dimensional & visual inspection of components and sub-assemblies
Perform First Article inspections and documentation
Perform pre-production part verification for new product development
Report and manage non-conforming product per QMS procedures
Maintain identification and traceability of parts per regulatory requirements
Maintain documentation for supplier certifications
Manage inspection criteria and inventory in computer-based inventory management system
Provide training to peers
Support a culture of quality in the manufacturing environment
Understand and support regulatory compliance in particular to 21CFR820 and ISO13485
Additional Responsibilities
Assist in management of MRB activities including segregation and disposition of materials
Assist in calibration activities and maintenance of monitoring and measuring equipment
Troubleshoot failures and nonconformities identified in new product development and production
Assist Quality Engineers in statistical analysis, investigations, and verification activities
Required Knowledge and Skills
Strongly demonstrated documentation skills
Knowledge of blueprint reading, using CMM and other precision measuring tools and fixtures
Knowledge of AQL levels contained in ANSI standards
Metrology Experience
Quality Inspection Experience
Ability to communicate instructions whether written, spoken, or in a diagram
Ability to work collaboratively with peers and team members
Strongly demonstrated attention to detail
Demonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project)
Basic Qualifications
High School Diploma/GED and minimum five (5) years of quality work experience
Team oriented with strong interpersonal skills
Preferred Qualifications
ISO 9001, ISO 13485 or FDA Regulated Medical Device experience
Associate degree and minimum three (3) years of quality work experience
IPC Certification
Certified Quality Inspector (ASQ)
SAP and Agile experience
CMM programming (Calypso software)
GD&T experience
Work Conditions
Manufacturing Environment
Must be able to lift 30 lbs
Daily tasks may include kneeling, squatting, or standing for an extended period of time
May travel up to 10% (for training as necessary)
Omnicell