Quality Control Technician - Intellectt : Job Details

Role: Quality Control Technician

Location: Portland, OR 97224

Duration: 6+ Months (Contract)

Shift Timings: 8:00 AM – 4:30 PM

Job Description:

We are seeking a Quality Control Technician to support the Quality Management System through various testing, inspection, and documentation processes. This role is integral to ensuring compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), while maintaining the highest standards in product quality.

Key Responsibilities:

• Product Testing & Documentation:
• Conduct product testing, including support for complaint investigations and stability verification.
• Generate test result reports and ensure thorough documentation of findings.
• Perform product acceptance testing, sampling, and inspection based on engineering dispositions.
• Batch Record Review & Compliance:
• Review production batch records (DHRs) for accuracy and completeness, approving intermediate products for further use.
• Ensure all deviations are documented, addressed, and resolved prior to issuing approvals.
• Review and verify compliance of finished goods batch records, inspection records, and nonconforming material reports.
• Inspections & Audits:
• Conduct spot-check inspections and audits of production operations to ensure adherence to quality standards.
• Participate in the internal audit program to drive continuous improvement.
• Audit processes such as line verification and environmental conformity.
• SOPs & Documentation:
• Write, review, and approve Standard Operating Procedures (SOPs) as required.
• Assist in managing the Document Control Program, including record retention and sample retention areas.
• Use CATSWeb to run queries and input lot and test data.
• Returned Instrument Processing (as applicable):
• Log, decontaminate (in a Biohazard Level II environment), and inspect returned instruments for damage.
• Document decontamination and investigation results, coordinating repairs when necessary.
• Process instrument documentation and prepare items for shipment to the repair facility.

Qualifications:

Education:

• Bachelor's degree in a scientific or technical discipline, or an equivalent combination of education and experience.
• At least 1 year of quality assurance experience in the medical device industry preferred.

Technical Skills:

• Ability to follow GMP and GLP practices.
• Proficiency in Database, Internet, Inventory, Spreadsheet, and Word Processing software.
• Ability to perform measurement for small parts using CNC or Vision Systems like SmartScope and Pull Testing.
• Experience with validation testing under engineering guidance is a plus.

Language & Mathematical Skills:

• Ability to read and interpret technical documents, safety protocols, and procedure manuals.
• Strong written communication skills for preparing reports and correspondence.
• Ability to apply mathematical concepts such as fractions, percentages, ratios, and proportions to practical situations.

Other Skills:

• Detail-oriented with a strong focus on procedure compliance and accurate documentation.
• Understanding of manufacturing processes and the ability to identify deviations from approved procedures.
• Ability to handle cleaning agents (e.g., bleach) for decontamination purposes.
• Strong organizational, analytical, and follow-up skills.
• Ability to work independently and in a team-oriented environment.