QA Engineer

QA Engineer

Vista, CA

Position Summary

The Quality Engineer is responsible for driving process excellence and executing strategic quality initiatives. Reporting directly to the Quality Director, this role does not manage people but serves as the ultimate champion and owner of quality processes. The ideal candidate acts as a cross-functional conduit of quality—collaborating with co-manufacturers, vendors, and internal teams during plant trials, managing non-conformances, and ensuring audit readiness.

Essential Functions

• Deviation Management: Review, investigate, and assess planned and unplanned process deviations; partner with teams to identify true root causes and implement robust corrective and preventive actions (CAPAs).
• Supplier Quality Investigations & SCARs: Issue, manage, and execute Supplier Corrective Action Reports (SCARs) for co-manufacturers and raw material/packaging vendors; perform diligent follow-ups to ensure timely containment, resolution, and compliance.
• Non-Conformance Tracking: Monitor, investigate, and follow up on Non-Conformance Reports (NCRs) from inception to final disposition, ensuring defective materials or products are properly segregated and tracked.
• SOP Training: Develop training materials and conduct regular employee training on Standard Operating Procedures (SOPs) to guarantee plant-wide alignment with regulatory guidelines and internal quality benchmarks.
• Plant & Packaging Trials: Serve as the on-the-floor quality conduit during plant trials and new packaging trials; provide real-time quality oversight, evaluate process capabilities, and document findings to ensure seamless scaling. Should be involved in new equipment or process validation in collaboration with R&D and Manufacturing Engineering counterparts.
• Audit Representation: Actively participate in, prepare documentation for, and support internal, third-party, and regulatory quality audits.
• Initiative Execution: Assist the Quality Director in rolling out corporate quality initiatives, continuous improvement projects, and data-driven quality programs across the organization.

Position Qualifications

Problem Solving & Root Cause Analysis: Proficient in structured problem-solving methodologies (e.g., 5 Whys, Fishbone diagrams, 8D) to resolve complex process issues.

Process Ownership & Autonomy: Demonstrated ability to manage, monitor, and optimize complex quality processes independently without requiring direct oversight of personnel.

Collaboration & Influence: Exceptional interpersonal skills to act as a collaborative partner and quality conduit between internal operations, co-manufacturers, and external vendors.

Detail-Oriented & Compliance-Driven: Uncompromising focus on documentation accuracy, regulatory standards, and meticulous record-keeping.

Project Management: Ability to prioritize multiple moving parts—such as simultaneous plant trials, open NCRs, and supplier follow-ups—while meeting critical deadlines.

Skills & Abilities

Education: Bachelor's degree in Engineering, Quality Management, Food Science, Chemistry, or a related technical discipline is required. ASQ Certified Quality Engineer (CQE) or equivalent quality certification is highly desirable.

Experience: 3–5 years of direct experience in a quality engineering or quality assurance role within a manufacturing environment. Proven experience working within regulated industries (e.g., dietary supplements, food manufacturing, pharmaceuticals, or medical devices). Hands-on experience managing vendor relationships, co-manufacturers, and executing SCAR/NCR workflows.

Computer Skills: High proficiency with Quality Management Systems (QMS) and Enterprise Resource Planning (ERP) software (e.g., SAP). Advanced knowledge of Microsoft Office Suite (particularly Excel for data tracking, Word for SOP drafting, and PowerPoint for training delivery).