Sr Inspector Jobs in Irvine, CA (NOW HIRING)

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 sizes, tolerances, and appropriate tool selection based on drawing requirements
• Ability to work effectively and collaborate with cross-functional teams
• Ability to articulate results and conclusions verbally and in writing to technical and non-technical personnel
• Ability to take initiative and conduct hands-on work
• Ability to work independently after training
• Ability to handle multiple tasks with high attention to detail
• Broad knowledge of operational systems and practices
• Ability to continuously expand proficiency in inspection techniques
• Strong hand-eye coordination and high manual dexterity
• Motivated, willing to learn, and able to ask questions when needed
• Ability to work in a fast-paced and changing environment
• High school diploma or equivalent required; candidates without a diploma may complete an employer-provided external assessment
• Ability to work onsite in Irvine, CA
• Ability to work 2nd shift from 2:30 PM to 11:00 PM
• Ability to train on 1st shift from approximately 6:00 AM to 2:30 PM for the first 2 to 3 months, or as needed
• Ability to work overtime as required based on production needs
• Ability to support a permanent opportunity
• No sponsorship available

Physical Requirements:

• Ability to work in a corporate office, laboratory, warehouse, and controlled cleanroom environment as needed
• Ability to work in a controlled cleanroom environment while wearing full cleanroom gowning, including gown or coveralls, gloves, mask, hairnet, boot covers, and other PPE as needed
• Ability to stand for extended periods during the work shift
• Ability to stand, walk, and sit for prolonged periods of time
• Ability to perform tasks requiring close visual acuity and strong attention to detail
• Ability to use hands and fingers to manipulate small tools and components
• Ability to use inspection tools, measuring devices, and testing equipment as part of routine job duties
• Ability to inspect components ranging from very small parts to larger parts or tubing as needed
• Ability to lift or move materials weighing up to 25 pounds
• Ability to push, pull, twist, climb, balance, stoop, kneel, and crawl as needed
• Ability to perform repetitive motions, including reaching and grasping
• Ability to follow strict safety, contamination control, quality, laboratory, and cleanroom protocols

Salary Range: $28 to $34/hour plus 5% bonus potential
More information can be found at www.simplybiotech.com.

Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.