Quality Control Inspector - Medical Device (FDA/GMP/ISO 13485)
Job DescriptionJob Description
Job Title: QA/QC Inspector
Location: Pleasanton, CA 94588 (100% On-Site Role)
Duration: 06 Months of contract to start with possible extension
Shift Timings: 06:00 AM – 02:30 PM
Main Purpose of the role:
• Performs inspection and testing of purchased materials, components, and products in accordance with policy and procedures.
• Assists Supplier Quality Engineering with technical inspection support.
Main Responsibilities:
• 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.
• Assists in the Development of inspection methods.
• Recommends changes to policies and procedures.
• 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.
• May assist in training other inspection staff in use of equipment.
• Requests certification from vendors.
• Assists in gathering, analyzing, and trending of data.
• Performs work of a miscellaneous nature as required.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Education Qualifications:
• High School Diploma / GED or an equivalent combination of education and work experience.
Experience/Background:
• 1-2 years’ experience in Quality performing inspection.
• Experience with CMMs, 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, Microsoft Excel, database entry, and use of statistical software packages.
• Prior medical device component inspection experience .
• ASQ CMI certification .
• 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.
• Experience working in a broader enterprise/cross-division business environment.
• Ability to work in a highly matrixed and geographically diverse business environment.
• 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.
Company DescriptionSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.
Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier awards, further validating our industry-leading capabilitiesCompany DescriptionSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.\r\n\r\nBased in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier awards, further validating our industry-leading capabilities