Reads and understands all Quality Management System procedures related to the position / function within the organization.
Experienced with measurement equipment.
Performs incoming, First Piece, in-process and final inspection per relevant specifications. Documents the results of these inspections on the appropriate Quality Plans.
Prepares Nonconforming Material Reports (NCMR) and Customer Deviation Requests (CDR) as applicable for discrepant materials and components.
Maintain accurate records within the Quality Assurance Database for inspection results and nonconforming material handling.
Review and approve material and special process certifications.
Prepares required documentation for finished product final release.
Reviews and releases for distribution, sterile product from Customer Inventory.
Review and verify Device History Records to ensure that all required documents are present, complete and accurate prior to scanning them into the Document Control System.
Execute protocols and support Engineering on special projects such as Gage R&R and Component Qualification.
Ensure that the Quality Assurance philosophy is disseminated to personnel in organization.
Maintain a working knowledge of industry Quality Assurance standards.
High School diploma or equivalent and three to five years’ experience in a Manufacturing or Quality Assurance environment or equivalent combination of education and experience. Working knowledge of FDA 21CFR820 Quality System Regulations (QSR) and ISO 13485 Quality Management Systems.
Experience in the proper use of the following instruments and tools:
· Micrometers, calipers, thread gages and similar manual instruments,
· Surface-plate set-ups, Micro-Hites, drop indicators
· Coordinate Measuring Machines
· Non-contact instruments such as comparators and vision systems.
Ability to read and interpret technical drawings and specifications.
Ability to write reports and business correspondence.
Ability to effectively present information and respond to questions from managers, employees and suppliers.
Ability to work with basic mathematical concepts
Ability to solve practical problems using a common sense approach.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Attention to detail.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Vision insurance
Schedule:
Education:
- High school or equivalent (Preferred)
Experience:
- Manufacturing: 1 year (Preferred)
Shift availability:
Work Location: In person
