Quality & Validation Engineer - Medical Manufacturing - Job ID: 251104

Quality & Validation Engineer (Contract-to-Hire)
Company: Medix
Location: Redmond, OR (On-site / Hybrid potential)
Compensation: $55.00 – $80.00 / hour (DOE)
Schedule: Monday – Friday, 7:00 AM – 4:00 PM

The Opportunity
Medix is seeking a high-level Senior Quality Engineer to lead critical process control and validation initiatives for a premier life sciences partner and medical manufacturer in Redmond, OR. This is a Contract-to-Hire role designed for a seasoned expert who thrives in technical problem-solving and regulatory excellence.

You will be the focal point for elevating quality systems, specifically addressing audit findings, updating procedures, and bridging the technical gap in Software and Manufacturing Execution Systems (MES) validation.

Key Responsibilities
Process Validation & Control: Manage the development and implementation of methods for process control, validation (IQ/OQ/PQ), and inspection.
Statistical Analysis: Design complex experiments to identify sources of variation using SPC methods, probability, and statistical quality control.
Quality System Improvement: Lead the response to audit findings by updating procedures, streamlining training, and optimizing the quality management system.
CAPA & Investigations: Direct investigations into non-conformances (NC) and out-of-specification (OOS) results, developing robust Corrective and Preventive Actions (CAPA).
Compliance & Design Control: Provide expertise in Risk Management, CE Technical Files, and Device Master Records (DMR) in compliance with ISO 13485 and CFR Part 820.
Supplier Quality: Lead supplier qualifications and collaborate with external partners on SCARs and quality improvement programs.

Technical Focus Areas
While this role covers broad QA Engineering, we are specifically looking for expertise in:
Software Validation: Experience with custom, home-built software and Manufacturing Execution Systems (MES).
Cleaning Validation: Leading technical needs for cleaning process protocols.
Regulatory Submissions: Supporting 510(k) submissions and letters to file.

Required Qualifications
Experience: 5–10+ years (senior title available) of Quality Assurance experience within a highly regulated engineering space (Medical Device, Pharma, or Aerospace).
Regulatory Mastery: Deep proficiency in ISO 13485 and FDA 21 CFR Part 820 standards.
Validation Expert: Proven track record with CAPAs, design controls, and validations.
Leadership: Ability to act as the Quality Lead in the absence of management and mentor junior team members.

Preferred Skills
Strong background in Software Quality Assurance (SQA) rather than just hardware/equipment.
Experience turning audit findings into actionable process improvements.
Background in cleaning process validation.

Why Apply Through Medix?
At Medix, we don't just find you a job; we manage your pivot into a long-term career.
High-Impact Work: Join a project where your expertise directly influences product safety and functional excellence.
Competitive Pay: Earn a premium hourly rate with a clear path to permanent employment.
Dedicated Support: Your Medix recruiter acts as your advocate, ensuring a smooth transition from contract to hire.
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