Senior Inspector, Receiving - 21252

Simply Biotech

Irvine, CA 92618, USA

Published: 6/14/2022

Manufacturing

Full Time

Job Description

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.

\nCompany Description

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.