QA Associate

Job Title:

QA Associate

Job Description

The QA Associate provides hands-on, on-the-floor quality support to the Quality team by performing inspections, managing documentation, and supporting nonconformance activities. This role plays a critical part in ensuring production meets quality standards, maintaining accurate records, and supporting both inspection and broader quality operations in a regulated medical device environment.

Responsibilities

* Perform in-process inspections on the manufacturing floor using calipers and other precision measurement tools to verify product quality.

* Conduct receiving inspections on incoming components and materials to ensure they meet specified requirements.

* Review Device History Records (DHRs) for Good Documentation Practice (GDP) compliance and verify that all documentation is complete, accurate, and traceable.

* Document inspection findings clearly and thoroughly, and verify that issues are resolved before providing final sign-off.

* Create, review, and close Nonconformance Reports (NCRs), ensuring accurate documentation of issues and actions taken.

* Participate in Material Review Board (MRB) activities to support evaluation and disposition of nonconforming materials and products.

* Support part movement and NCR-related transactions within the ERP system (IFS), ensuring accurate data entry and traceability.

* Review and release quality documentation in alignment with quality management system (QMS) and document control requirements.

* Assist with reducing backlog in receiving inspection and quality documentation processes by prioritizing tasks and maintaining steady throughput.

* Interpret engineering drawings and CAD information to support accurate inspection and verification of components within finished medical devices.

* Maintain a strong presence on the manufacturing floor, partnering closely with QA, QE, and MRB teams to support daily quality operations.

* Communicate effectively with cross-functional teams to resolve quality issues and ensure alignment on inspection and documentation expectations.

Essential Skills

* Hands-on quality experience in a regulated environment, preferably within medical devices.

* Proficiency in performing in-process and receiving inspections using calipers and other precision measurement equipment.

* Experience reviewing Device History Records (DHRs) for GDP (Good Documentation Practice) compliance.

* Demonstrated ability to manage the full Nonconformance Report (NCR) lifecycle, including creation, coordination with MRB, and closure.

* Ability to interpret engineering drawings and understand how components fit within a finished medical device.

* Familiarity with ERP systems, preferably IFS, for managing part movement and NCR transactions.

* Experience working within a Quality Management System (QMS) and following document control procedures.

* Strong attention to detail and a high level of accuracy in documentation and data entry.

* Ability to work effectively in a fast-paced production environment with a high volume of daily tasks.

* Strong communication skills and the ability to collaborate with cross-functional teams.

* Coachable mindset, open to learning new systems, processes, and tools.

* Ability to take initiative and work with minimal oversight while maintaining alignment with team goals.

Additional

Skills & Qualifications

* Experience with CAD or the ability to read and interpret CAD-based drawings to support inspection activities.

* Prior exposure to medical device manufacturing or other highly regulated industries.

* Experience participating in MRB activities and cross-functional quality investigations.

* Comfort working both independently and as part of a collaborative team.

* Demonstrated ability to adapt to organizational changes while maintaining a positive, solutions-focused approach.

* Interest in gaining broader exposure to QA processes, including NCR management, MRB participation, and quality documentation.

Work Environment

This is an on-site, first-shift role in a hands-on manufacturing floor environment, typically operating from 6:00 AM to 2:30 PM. The position involves a mix of physical inspection work and detailed documentation review, requiring frequent use of standard inspection tools such as calipers and other measurement equipment. The environment is fast-paced with a high volume of daily tasks and regular cross-functional interaction with QA, QE, and MRB teams.

The company offers a collaborative and supportive culture, with a smaller-company feel and accessible leadership. Team members benefit from wellness programs with incentives, including gift card rewards, as well as a strong benefits package. Dress and conduct are aligned with a professional manufacturing and quality-focused setting, emphasizing safety, accuracy, and teamwork.

Job Type & Location

This is a Contract to Hire position based out of San Diego, CA.

Pay and Benefits

The pay range for this position is $25.00 - $30.00/hr.

Eligibility requirements apply to some benefits and may…