About us

Vein360 is a small business in Blue Ash, OH and industry leader, bringing cutting edge environmentally friendly engineering and technology to new and existing markets. We are experiencing growth through new product development, and outstanding customer centric service and support. We possess a robust research infrastructure that translates into medical device reprocessing production.

**Job Summary:**

We are seeking a meticulous Quality Technician to join our team. The ideal candidate will be responsible for ensuring the quality of reprocessed medical devices to review and approve the output of daily operations (device history records), release raw materials to production, and to actively drive and support the management of process improvement activites such as Corrective & Preventive Action (CAPA). The Quality Technician is to become an expert in each phase of reprocessing operations and able to provide meaningful input to operations leadership and quality assurance for the continuous improvement of these operations.

**Responsibilities:**

Review and approve medical device production activities for compliance with quality standards before they can proceed to the next stage of production.

Initiate, develop, and update Standard Operating Procedures (SOPs) and Work Instructions for product release

Assist with investigating customer complaints, non-conformances, deviations, and deficiency reports to identify and document the cause, outcome, correction, and preventative measures.

Oversee and assist with the maintenance of records, archival process, and general document control

Participate with production, engineering, and other activities in developing plans and procedures for assuring quality and reliability of products;

Monitor quality of materials and supplies required to support production activities;

Conduct audits of products and processes for conformance to specifications and to detect processing and technical documentation deficiencies and recommending corrective action, including establishment of acceptable quality levels and statistical techniques.

Coordinate water quality sample collection and shipment for third party laboratory testing.

Review and approve sterilization reports for compliance with process specifications for medical device sterilization.

Strictly adhere to all corporate environmental health and safety programs including bloodborne pathogens and hazard communication

MINIMUM REQUIREMENTS:

Education:

Minimum: Associates degree

Preferred: Bachelors in Science

Experience:

3 years of quality technician or relevant experience within FDA regulated medical device operation

Preferred Skills/Qualifications:

Functional knowledge of 21 CFR 820 (Quality System Regulation) with specific experience with:

· Production & Process Controls

· Records (including Good Documentation Practices)

· Identification & Traceability

· Nonconforming Product

· Acceptance Activities

· Preventive Maintenance & Calibration

Working knowledge of various pieces of test and measuring equipment including:

· Micrometers, calipers, digital force gages, motorized test stands, rulers, digital multimeters, laser diode counters, temperature/humidity loggers, etc.

Familiar with critical manufacturing processes such as packaging and terminal sterilization, including monitoring of controlled environments.

Skills/Competencies:

· Time management

· Root cause analysis

· Functional knowledge of Microsoft Office (Word and Excel)

· Technical writing

· Basic data aggregation and analysis capabilities (e.g., summary statistics)

Other Skills:

· Safety & quality focused

· Detail oriented

· Creative problem solving

· Interpersonal skills

· Adept at multitasking

Join our team as a Quality Technician and contribute to maintaining the highest standards of quality in our products.

Job Types: Full-time, Permanent

Pay: $20.00 - $28.00 per hour

Expected hours: 40 per week

Benefits:

• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Experience:

• Quality control: 3 years (Required)

Shift availability:

• Day Shift (Required)

Ability to Commute:

• Blue Ash, OH 45242 (Required)

Ability to Relocate:

• Blue Ash, OH 45242: Relocate before starting work (Required)

Work Location: In person