Sr. Inspector, Quality Control; Medical Device

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…