Senior Inspector, Receiving - Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.

Immediate opening for a Senior Inspector, Receiving in Irvine, CA who possesses:

• High school diploma or equivalent required; candidates without a diploma may complete an employer-provided external assessment
• 5+ years of quality inspection experience with exposure to receiving inspection activities
• Working knowledge of Geometric Dimensioning and Tolerancing
• Experience within an ISO 13485 environment highly preferred

FULL DESCRIPTION: We are seeking a Senior Inspector, Receiving to perform receiving inspections on incoming materials in a highly regulated medical device environment. This permanent role is responsible for mechanical, visual, and functional inspection of materials, inspection record maintenance, NCR initiation, documentation review, supplier quality support, and collaboration with Engineering and Supplier Management teams. The ideal candidate will have strong quality inspection experience, receiving inspection exposure, GD&T knowledge, GDP documentation skills, and the ability to inspect a wide variety of components accurately in a fast-paced environment.

The selected candidate will be responsible for:

• Performing receiving inspection tasks for incoming materials
• Completing mechanical, visual, and functional inspection of materials
• Using measuring devices and testing equipment to assess product quality
• Inspecting a variety of components, including plastic, injection molded, metal, catheter, and related medical device components
• Reviewing and interpreting engineering drawings and specifications
• Using inspection tools such as calipers, micrometers, height gauges, pin gauges, laser micrometers, vision systems, and similar inspection equipment
• Maintaining and filing inspection reports and records
• Maintaining the inspection area in a clean and orderly fashion
• Complying with quality management system policies and procedures
• Initiating Non-Conformance Records
• Assisting with material containment, root cause investigations, and corrective actions
• Partnering with engineers and supplier management personnel to resolve issues, nonconformances, and CAPA items as applicable
• Participating in special projects, including test method validations, protocols, and first article inspections
• Supporting the training of other inspectors through work demonstration and feedback
• Prioritizing inspections based on business needs
• Participating in or leading process improvement initiatives within the inspection area
• Completing inspection documentation accurately and in accordance with GDP requirements
• Supporting fast-paced inspection needs while maintaining accurate paper-based records
• Collaborating with cross-functional teams as needed
• Maintaining reliable and consistent attendance to support production operations
• Working full scheduled shifts and overtime as required to meet operational and production needs
• Performing other duties as assigned

The selected candidate will also possess:

• 5+ years of quality inspection experience required
• Receiving inspection experience required
• Medical device quality inspection experience preferred
• Aerospace quality inspection experience may be considered
• Experience working within a quality management system in a highly regulated industry required
• ISO 13485 experience highly preferred
• Working knowledge of Geometric Dimensioning and Tolerancing required
• Ability to read and interpret engineering drawings and specifications required
• Experience inspecting different component types, including plastic, injection molded, metal, catheter, and visually inspected components, preferred
• Proficiency using basic inspection tools such as calipers, micrometers, height gauges, and pin gauges required
• Experience with laser micrometers, vision measurement systems, Keyence, or similar inspection equipment preferred
• Strong background in Good Documentation Practices required
• Experience maintaining handwritten or paper-based inspection records preferred
• Strong documentation skills
• Ability to assess certificates, records, and documentation for compliance preferred
• Ability to understand sample s