4550 Norris Canyon Road San Ramon, CA 94583 US
Position Summary: Performs inspection and testing of purchased materials, components and products in accordance with policy and procedures. Assists Supplier Quality Engineering with technical inspection support.
Essential Functions: Performs visual, dimensional and functional inspection and testing according to documented policies and procedures. Records inspection and test data as prescribed by written instructions and procedures. Operates all associated test and measurement equipment as instructed and as documented in procedures. Develops inspection methods. Write procedures for inspection methods. Support validation/qualification activities Develops and recommends changes to inspection procedures. Ability to program CMM and Optical systems. Proficiency in SAP with respect to incoming material QC requirements Recommends changes to policies, procedures and inspection requirements. Documents non-conformances in Non-Conforming Material Review system. Participates in GR&R studies as directed by engineers or technicians. Collects and analyzes data for First Article inspections. Performs testing and inspection in accordance with special test requests. Contributes to test and measurement equipment selection. Interface with suppliers as required in support of material quality / technical inspection May train other inspection staff on use of equipment. Assists in gathering, analyzing, and trending of data
Other Duties: Performs work of a miscellaneous nature as required Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
- HS Diploma or combination of experience and education
- 0-2 year’s experience. Previous experience in Quality performing inspection. Prior medical device component inspection experience preferred. Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing. Training in blueprint reading and experience with inspection sampling techniques. Knowledge of FDA, GMP, ISO 13485. Good communication and computer skills, including Microsoft Word and Excel. ASQ CMI certification preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Must be willing to work overtime as required, including weekends
- Ability to maintain regular and predictable attendance
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.