Quality Control Technician

Description of Activities: The Quality Technician works with internal customers to support the Quality Objectives. The Quality Technician ensures product meets specifications and that processes are being followed. The Quality Technician is responsible for programming QC equipment, representing Quality and making decisions that influence the Quality of the Medical Devices being manufactured.

Primary Duties:

· Develop and Improve inspection and product verification/acceptance processes

· Programming and maintaining programs through change control processes

· Perform Receiving, In-Process, and Final inspections of manufactured assemblies, sub-assemblies, and components to determine if required drawing and specification requirements are met.

• Evaluate the acceptability of parts against engineering documentation including but not limited to drawings, specifications, BOMs and inspection checklists.
• Maintain organization and cleanliness of QC lab.
• Maintain organization, storage, and calibration compliance of tools in the lab.
• Prepare detailed inspection reports and defect summaries, as needed.

· Perform a variety of mechanical inspections, tooling inspections, and qualifications. This includes GD&T inspection and testing using calibrated measuring equipment, custom inspection, and testing tools and fixtures.

· Ensure compliance with FDA, COFEPRIS, and all procedural requirements.

· Participate in Nonconforming Material process.

• Document all nonconforming conditions in a complete manner.
• Ensure all defects are clearly identified and documented to allow subsequent processing of the disposition/MRB.

Secondary Duties:

· Participate in internal and external audit program and be audited.

· Participate in CAPA program as requested.

· Support Operations IQ/OQ/PQ activities, when applicable.

· Support and may participate in Management Reviews.

· Other duties and projects assigned.

Critical Knowledge, Skill, and Abilities:

· Strong written and verbal communication.

· Previous technical expertise in mechanical inspection techniques, best practices, and equipment usage.

· Previous quality systems experience performing inspector functions compliant with 21 CFR 820 and ISO 13485

· Experience with measuring instruments (Micro-Hite, microscope, optical comparator, micrometer, caliper, Keyence etc.).

· Experience with Geometric Dimensioning and Tolerancing (GD&T).

· Ability to handle multiple tasks while maintaining attention to detail and accuracy, working under tight time constraints.

· Excellent interpersonal skills and ability to collaborate with cross functional teams.

· Working knowledge of MS Outlook, Word, and Excel.

Experience/Education:

· 2 years minimum mechanical inspection experience

· Associated degree in engineering (Mechanical, Biomedical, Industrial etc.) or 2 years of related experience

· Knowledge of FDA QMSR and ISO 13485 regulations

Job Types: Full-time, Permanent

Pay: $32.00 - $35.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Tuition reimbursement
• Vision insurance

Education:

• High school or equivalent (Required)

Work Location: In person

Salary : $32 - $35