Overview

We are looking for a talented individual to join our dynamic Keystone Manufacturing team located in Kalamazoo, MI. The Quality Technician is a motivated, self-starter who will assist and ultimately lead the QC processes to ensure labeling, material, and product conformity within the Keystone Manufacturing QMS.

The successful candidate must be capable of working with minimal supervision, have a “can do” attitude, possess creative problem-solving skills and be willing to do “whatever it takes” to complete assigned tasks efficiently and effectively. This candidate must have excellent attention to detail and be highly organized with the ability to multi task with minimum interruption to work progress. Excellent interpersonal skills while working with high customer visibility are also critical to success in this opportunity.

The Quality Technician will work with Production, Sourcing/Purchasing, and Quality Assurance while carrying out duties for this position. The Quality Technician will report through the QC Department and will be responsible for performing dimensional, functional and visual inspections utilizing ANSI/ASQ sampling plans and initiating non-conforming material reports.

Responsibilities and Activities

Ensures incoming material and outgoing product adhere to customer and Keystone specifications, SOPs, Federal Regulations, and International Standards while following good documentation practices.
Performs dimensional, functional and visual inspections of all finished product and approves products for release and shipment.
Performs inspections of incoming materials and approves for use in manufacturing.
Initiates non-conforming material reports and notifies the Quality Manager.
Maintain inspection paperwork ensuring its completed according to applicable requirements and good documentation practices.
Listen and work with others to contribute new ideas.
Must demonstrate a commitment to quality and customer satisfaction for both internal and external customers, and maintain a high standard of ethics.

Minimum Requirements and Qualifications

Minimum of 1 – 3 years of inspection experience or manufacturing background where checks for product quality were an important part of daily responsibilities.
Familiarity with measurement equipment: calipers, rulers, micrometers, etc.
Familiarity with ISO Standards and GMP preferred.
Must be able to routinely make decisions that immediately impact operations.
Must be able to understand and execute tasks per Standard Operating Procedures and Customer Specifications.
Must have the ability to operate hand tools, inspection equipment, and common office equipment.
Must have the ability to operate in a fast-paced environment
Must have excellent interpersonal communications skills to ensure core corporate values are demonstrated and promoted to all coworkers.
Must have excellent documentation and organizational skills.
Experience with sterile barrier packaging is a plus.
Experience working in a clean room is a plus.
Experience with single use disposable medical devices is a plus.
Experience with seal integrity and seal strength testing is a plus.
References must be provided upon request.
Basic computer skills (word processing, spreadsheets, database)

Benefits

Excellent full-time benefits, including comprehensive medical coverage, dental and vision options
Company paid life insurance, short term disability and long-term disability insurance
Retirement savings plan with company match
Paid time off and holidays, with the ability to schedule a day of volunteering once per quarter

Schedule

This position has the option of Monday-Thursday 6a-4:30p. sometimes requiring extended work hours, including evenings, weekends and holidays to ensure minimal interruption to production. The work environment for this position will be both an office environment and manufacturing work cells and cleanroom environments.