Sr. Inspector, Quality Control (Medical Device) - 21383

Job Description

Job Description

Sr. Inspector, Quality Control (Medical Device) - 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  Sr. Inspector, Quality Control in  Irvine, CA who possesses:

• 2+ years of Quality Control inspection experience within the medical device industry
• Knowledge of quality control systems, GDP, GMP, and inspection techniques
• Experience neatly documenting and reviewing DHRs, NCRs, and sterilization documentation
• Experience working in a regulated medical device or precision manufacturing environment
• Strong attention to detail and ability to work in a cleanroom environment

FULL DESCRIPTION:   We are seeking a Sr. Inspector, Quality Control to support inspection, testing, documentation review, DHR release, nonconformance support, and product release activities within a regulated medical device manufacturing environment. This permanent, onsite role is responsible for performing in-process and final inspections of delivery system subassemblies and finished products, reviewing Device History Records, supporting NCR initiation and follow-up, assisting with raw material inspection, training inspectors and technicians, and supporting cleanroom quality activities. The ideal candidate will have medical device QC inspection experience, strong GDP/GMP knowledge, clean documentation habits, DHR and NCR experience, and the ability to support fast-paced production quality needs with accuracy and professionalism.

The selected candidate will be responsible for:

• Performing in-process and final quality inspections of medical device delivery system subassemblies and finished products
• Performing visual inspection, dimensional verification, and functional testing according to approved work instructions, SOPs, and quality procedures
• Reviewing Device History Records for completeness, accuracy, and conformance to acceptance criteria
• Ensuring documentation complies with Good Documentation Practices and GMP requirements
• Supporting product release to Finished Goods Inventory upon successful completion of quality requirements
• Conducting inspection of device labeling, including UDI human-readable content and barcode verification
• Identifying quality issues, documentation concerns, inspection issues, and process deviations
• Initiating Non-Conformance Reports as needed
• Assisting with material containment, root cause investigations, and corrective actions
• Supporting raw material inspection and material release to inventory as needed
• Prioritizing inspection activities based on manufacturing and product development demands
• Providing hands-on guidance and technical support to inspectors and manufacturing technicians
• Reinforcing proper inspection techniques and quality standards
• Assisting in onboarding and training new inspectors and technicians
• Supporting engineering and quality teams in process validations
• Participating in continuous improvement initiatives and providing practical feedback
• Completing required training and maintaining qualification for assigned inspection processes
• Supporting technical review, functional testing, nonconformance review, record review, and DHR release activities
• Working in a controlled cleanroom environment as required
• Supporting paper-based documentation review during system transition periods
• Communicating inspection results verbally and in writing to engineering, management, and cross-functional teams
• Maintaining reliable attendance and supporting production operations
• Working overtime as required to meet operational and production needs
• Following company policies, quality system requirements, safety procedures, and cleanroom protocols
• Performing other duties as assigned

The selected candidate will also possess:

• High school diploma or equivalent required
• 2+ years of Quality Control inspection experience within the medical device industry required
• 3+ years of Quality Control inspection experience within medical device or regulated precision manufacturing preferred
• Medical device manufacturing experience required
• Class III medical device experience preferred
• Experience with delivery systems, catheter-based devices, structural heart devices, or similar medical device products preferred
• Knowledge of quality control systems required
• Strong knowledge of GDP and cGMP required
• Strong knowledge of inspection techniques required
• Experience reviewing Device History Records required
• Experience neatly documenting and correcting paper-based records required
• Experience with NCR initiation, investigation, or follow-up preferred
• Sterilization documentation experience preferred
• Experience with in-process inspection required
• Experience with final inspection required
• Experience with visual inspection, dimensional verification, or functional testing required
• AQL sampling experience preferred
• Design specification review experience preferred
• Raw material inspection experience preferred
• Product release or Finished Goods Inventory release experience preferred
• Experience inspecting device labeling, UDI information, or barcode verification preferred
• Experience working in a controlled cleanroom environment required
• Ability to wear full cleanroom gowning and required PPE
• Ability to work effectively in a regulated manufacturing environment
• Ability to follow written procedures, work instructions, and quality standards
• Ability to identify quality issues and contribute to troubleshooting and problem-solving activities
• Ability to mentor inspectors and technicians and provide hands-on technical guidance
• Strong attention to detail required
• Strong written and verbal communication skills required
• Ability to communicate inspection results clearly to engineering and management
• Basic computer skills required
• MS Office experience preferred
• Ability to read, comprehend, and speak English required
• Self-motivated, flexible, and team-oriented work style required
• Ability to prioritize tasks in a fast-paced production environment
• Ability to work onsite in Irvine, CA
• Ability to work Monday through Friday from 5:00 AM to 2:00 PM
• Ability to work overtime as required
• Ability to support a full-time, permanent opportunity
• No sponsorship available

Physical Requirements:

• Ability to stand and sit for prolonged periods while supporting inspection, testing, documentation review, and product release activities
• 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 follow cleanroom, laboratory, site safety, quality, and manufacturing protocols at all times
• Ability to use inspection and testing equipment as part of routine job duties
• Ability to push, pull, twist, climb, balance, stoop, kneel, and crawl as needed
• Ability to perform repetitive motions, including reaching and grasping
• Ability to lift or move materials up to 25 pounds
• Ability to use hands and fingers for inspection, testing, documentation, computer entry, record review, labeling review, and standard quality tasks
• Ability to visually inspect medical device components, subassemblies, finished products, labeling, documentation, and quality records for accuracy and conformance
• Ability to review DHRs, NCRs, work instructions, SOPs, quality procedures, inspection results, and computer screens for extended periods
• Ability to maintain focus, accuracy, and attention to detail while working in a regulated medical device and cleanroom environment

Salary Range: $29/hour plus 5% bonus potential

More information can be found at \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.

Company 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.