Quality Assurance Inspector/Technician – Medical Devices

Primary Function:

This is an exciting opportunity to participate in KDI’s rapid growth cycle and contribute to the extraordinary customer experience through ensuring product quality for a variety of medical devices. Working in the dynamic medical device contract manufacturing environment, the Quality Assurance Inspector/Technician will have a strong grasp of inspection and documentation methodologies in an ISO 13485 environment. This individual will be responsible for performing raw materials and in-process inspections, reviewing device history records, and assist other quality team members with a variety of quality assurance tasks to support production. Quality Assurance Inspector/Technician will develop basic understanding of electro-mechanical assembly, CNC machining, and clean room operation.

Responsibilities:

• Serve as manufacturing floor support for product inspection and disposition and other activities as assigned.
• Perform component and product receiving, in-process and finished good inspections.
• Assure all quality system documentation and record keeping activities are carried out and completed in compliance with established procedures and work instructions.
• Assist with qualification/validation protocol execution.
• Assist with all quality systems investigations (NCMR, CAPA, SCAR, Complaint, etc)
• Assist in complaint product processing receipt, failure analysis, and disposal.
• Collect data for quality system metrics.
• Participate in internal audits
• Help maintain CAPA and calibration systems

Qualifications:

Required Qualifications

• High school diploma or equivalent.
• 3 years of relevant experience in a regulated industry.
• Basic proficiency with computers.

Preferred Qualifications and Competencies

• Some manufacturing experience/exposure is desired.
• Ability to multi-task in a fast-paced environment.
• Strong communication and interpersonal skills.
• Demonstrated ability to learn and execute projects.
• Strong attention to detail, analytical and problem-solving skills.
• Understanding of cGMP and/or ISO 13485 is a plus.
• Experience with machining and / or assembly of Class I and Class II medical products.
• Experience with measurement tools (calipers, gage pins) and automated measurement equipment (Micro-Vu, CMM, etc.).
• Able to adapt to changing duties and responsibilities.
• ‘Can-do-it’ attitude is a must.

Job Type: Full-time

Pay: $22.00 - $28.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement

Ability to Commute:

• Rogers, MN 55374 (Required)

Ability to Relocate:

• Rogers, MN 55374: Relocate before starting work (Required)

Work Location: In person

Salary : $22 - $28