We are seeking a Mechanical Inspector to join our Quality Control team! You will perform all aspects of Incoming, In-process and Final Inspection of materials, components and finished medical products. The Mechanical Inspector performs the following duties:
Essential Duties and Responsibilities:
- Reads and understands all Quality Management System procedures related to the position / function within the organization.
- 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.
This position has no direct supervisory responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education and/or Experience
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.
- 20/20 corrected vision and / or ability to distinguish colors, see fine imperfection and flaws Computer Skills
- Individual should have a good working knowledge of the elements within Microsoft Office and Adobe Acrobat. ,
To be considered, please click "Apply Now."