Job Description

Ultimate Staffing is seeking a Sr. Quality Receiving Specialist to join a medical device client. This position is 100% onsite at their facility in San Jose. Hours are Monday - Friday 8:00 am - 5:00 pm. This is a 9 month contract position with potential to become a full-time employee.

The Senior Quality Receiving Specialist is a key member of the Quality team, responsible for performing dimensional, visual, and functional inspections of incoming products to ensure they meet documented specifications (e.g., drawings, procedures, and work instructions). This role also ensures accurate record-keeping in compliance with ISO 13485 and internal quality procedures.

Additionally, the specialist oversees the instrument calibration process, managing certificate documentation, coordinating logistics for instrument shipments, and maintaining effective communication with calibration vendors.

Job Duties:

• Conduct first article and routine incoming inspections to verify product quality.
• Ensure ongoing compliance with global regulatory standards, including MDSAP and EU MDR.
• Create, update, and maintain inspection records and documentation.
• Coordinate and distribute tasks within the Receiving Inspection area.
• Collaborate with engineering teams to communicate quality issues, concerns, and observations.
• Initiate non-conformance reports and support related investigations as needed.
• Manage calibration activities with external vendors, including scheduling, documentation, and vendor coordination.
• Maintain a comprehensive inventory of calibrated instruments and coordinate instrument distribution with the logistics and service engineering teams.
• Store and manage calibration certificates within the Quality Management System (QMS).
• Support additional quality-related initiatives and tasks as assigned.

Requirements:

• Minimum of 8 years of experience as a Quality Inspector in a medical device manufacturing environment.
• Proficiency in the use of precision measurement tools (e.g., calipers, micrometers, gage pins, go/no-go gages).
• In-depth knowledge of ISO 13485 and applicable regulatory requirements, including FDA 21 CFR Part 820.
• Demonstrated ability to work effectively within the framework of the company's Quality Policy and directives.
• Strong computer skills and proficiency in Microsoft Office applications.
• Ability to read, interpret, and follow written and verbal instructions in English.
• Hands-on experience with initiating and managing non-conformance reports.

Preferred Experience:

• Experience using Agile or similar document control systems.
• Proficiency with vision inspection systems.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

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