Quality Control Inspector

Enovis•Vista, CA

8d•Onsite

About The Position

We are seeking a QA Complaint Inspector to support complaint handling activities within a regulated medical device manufacturing environment. This role is responsible for performing detailed inspections, evaluations, and documentation of returned products and complaint-related materials to ensure compliance with internal procedures, regulatory requirements, and quality standards. The ideal candidate is detail-oriented, analytical, and capable of working both independently and collaboratively to support timely and compliant complaint investigations.

Requirements

High school diploma or equivalent (Associate degree in a technical field preferred)
Minimum 1–2 years of experience in quality inspection, complaint handling, or medical device manufacturing
Basic knowledge of inspection methods, sampling techniques, and documentation practices in a regulated environment
Familiarity with inspection tools (calipers, micrometers, gauges) and basic testing equipment
Working knowledge of Microsoft Office applications (Word, Excel, Outlook)
Strong written and verbal communication skills
Ability to follow established procedures and recognize when escalation or deviation from standard practice is required
Detail-oriented with strong analytical and documentation skills
Ability to work under general supervision and follow instructions for new or complex tasks

Nice To Haves

Familiarity with complaint handling systems (e.g., electronic quality management systems)
Basic understanding of FDA 21 CFR Part 820 and ISO 13485 requirements
Ability to stand or sit for extended periods while performing detailed inspection activities
Ability to lift/pull/carry up to 25 lbs
Ability to perform repetitive tasks with sustained attention to detail
Demonstrated ability to work effectively in cross-functional teams within a fast-paced manufacturing environment

Responsibilities

Perform inspection, evaluation, and testing of returned medical devices associated with customer complaints
Conduct visual, functional, and dimensional inspections in accordance with approved procedures and specifications
Document inspection findings clearly and accurately within complaint handling systems and quality records
Support sampling and testing activities for complaint investigations, including incoming components or raw materials when required
Apply approval, rejection, or quarantine identification as appropriate based on inspection outcomes
Monitor and verify proper functioning of inspection tools, test equipment, and instrumentation used during complaint evaluations
Collaborate with Quality Engineering, Manufacturing, and Regulatory teams to support root cause analysis and corrective actions
Assist in drafting or revising inspection procedures and support validation or troubleshooting of test methods when applicable
Ensure compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and internal quality system requirements
Maintain accurate records in accordance with Good Documentation Practices (GDP)
Support audit readiness by ensuring complaint files and inspection records are complete and compliant