Quality Engineer - #260265

Medix™; San Diego (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Medix Staffing Solutions, Inc. seeks a Quality Engineer to execute standard quality engineering assignments for medical device projects, applying rigorous problem solving and conformance assessment to ensure regulatory compliance.

You will use FMEA, SPC, DOE tools, perform design/process qualifications, support CAPAs/NCRs, and collaborate with cross-functional teams to drive quality improvements on-site in San Diego, Monday–Friday 8:00 AM–5:00 PM.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences or related technical discipline.
• Strong ability to analyze data and resolve engineering problems of moderate complexity.
• Strong verbal and written communication skills; comfortable drafting technical documentation.
• Ability to prioritize and multitask effectively in a fast-paced manufacturing environment.

Responsibilities

• Utilize standard quality engineering tools to solve issues of moderate scope (FMEA, SPC, DOE).
• Analyze production and quality data to identify issues and drive root-cause resolution.
• Implement design, process, and material changes to improve quality and efficiency.
• Execute equipment and process qualifications and validations using IQ/OQ/PQ.
• Perform TMV and Gauge R&R studies; support risk management (ISO 14971).
• Collaborate with Calibration to review calibration requirements and investigate OOT events.
• Ensure compliance with FDA QSR, ISO, EN, AATB and related regulations.
• Support NCRs, CAPAs, and customer complaints; assist post-market quality operations.
• Support document control and design control deliverables; participate in regulatory inspections.

Skills

Data analysis

Problem solving

Documentation

Cross-functional collaboration

Education

Bachelor’s Degree in Engineering or Life Sciences

Job description

Schedule / Shift: Monday – Friday, 8:00 AM – 5:00 PM

Location / Work Setting: On-site

Position Overview

We are seeking a Quality Engineer to execute standard quality engineering assignments as a vital component of ongoing and new project initiatives. In this role, you will apply sound technical problem-solving techniques, assess product and process conformance, and collaborate cross-functionally to ensure strict adherence to medical device quality standards and regulatory compliance.

Key Responsibilities & Essential Functions

Quality Engineering & Continuous Improvement

• Utilize standard quality engineering tools to solve technical problems of moderate scope (e.g., FMEA, SPC, DOE).
• Analyze complex production and quality trend data to identify issues and drive root-cause resolutions.
• Implement design, process, and material changes to enhance overall product quality, reliability, and manufacturing efficiency.
• Recommend material and process specifications; assess operational results for validity and conformance.
• Execute equipment and process qualifications and validations using IQ, OQ, and PQ methodologies.
• Perform Test Method Validations (TMV) and Gauge R&R studies.
• Support Risk Management and risk assessment activities (including HHE, ISO 14971 compliance).
• Collaborate with the Calibration department to develop gauging, review/approve calibration requirements, and investigate Out-of-Tolerance (OOT) events.

Compliance, Audits & Quality Systems (QMS)

• Ensure continuous compliance with FDA QSR, ISO, EN, AATB, and applicable international regulations.
• Provide investigational QA support for Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and customer complaints.
• Support post-market quality operations, including complaint trending, CAPAs, and Field Corrective Actions (FCAs).
• Facilitate document control, engineering change orders (ECOs), and design control deliverables across the product lifecycle.
• Participate in external regulatory inspections (e.g., FDA inspections, ISO certification/surveillance audits) and customer audits.

Cross-Functional & Supplier Quality Support

• Support New Product Introductions (NPI) to ensure smooth, quality-compliant transitions into full-scale production.
• Interface directly with suppliers to review specifications, resolve supplier quality issues, and issue Supplier Corrective Action Requests (SCARs).
• Participate in supplier qualification and conduct internal and supplier audits.
• Lead small project teams as needed to accomplish target objectives.

Qualifications

Minimum Qualifications

• Education: Bachelor’s Degree in Engineering, Life Sciences, or a related technical discipline.
• Technical Skills: Strong technical aptitude with proven ability to analyze data and resolve engineering problems of moderate complexity.
• Communication: Strong verbal and written communication skills; comfortable presenting findings and drafting technical documentation.
• Work Style: Ability to prioritize and multitask effectively in a fast-paced manufacturing environment.

Preferred Qualifications

• Industry Experience: 1+ years of experience in the medical device, tissue banking, or regulated life sciences industry (an equivalent combination of an advanced degree and relevant experience will also be considered).
• Certifications: ASQ Certification (e.g., CQE, CQA, Six Sigma Green/Black Belt) is a plus.
• Regulatory Familiarity: Practical knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, 21 CFR Part 1271, and/or AATB standards.

Physical Demands & Environmental Conditions

In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential functions.

• Physical Movement: Frequent or continuous standing, walking, bending, stooping, kneeling, crouching, and repetitive hand/wrist/finger motions or grasping.
• Lifting & Handling: Frequent or continuous moderate lifting (15–40 lbs), pushing, and pulling.
• Work Environment: Frequent or continuous exposure to cleanroom or manufacturing plant conditions, which may include airborne irritants (dust, fumes, odors) and routine handling of chemicals/solvents with appropriate PPE.