Medical Device Packaging Specialist

We are looking for a talented individual to join our dynamic Keystone Manufacturing team located in Kalamazoo, MI. A Medical Device Packaging Specialist is a motivated self-starter who effectively follows Keystone’s SOPs to assemble and package products on time while ensuring specifications are met and maintaining the production environment. The specialist will complete visual inspections and other testing as required to identify non-conformities in parallel with production.

A successful Medical Device Packaging Specialist 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 team member should have excellent interpersonal skills, great attention to detail and be highly organized with the ability to multitask with minimum interruption to work progress.

***We are currently looking for candidates to join our team for 2^nd shift 2pm-12am Monday-Thursday. All training will be completed on 1^st shift 6am-4:30pm Monday-Thursday for 6-8 weeks, then employees will move to 2^nd shift.

Responsibilities and Activities

• Responsible for assembly and packaging of medical devices according to Keystone Standard Operating Procedures (SOP)
• Responsible for following all established policies, practices and procedures related to all job duties
• Responsible for following all Good Documentation Practices (GDP), Good Manufacturing Practices (GMP) and SOPs as defined by Keystone’s policies, practices and procedures to ensure that FDA regulations, ISO Standards and Keystone quality standards are met
• Prepare work area and keep it safe, clean and organized per Keystone standards
• Generate product label per specification to support Keystone production needs
• Verify accuracy of product produced against specification and resolve discrepancies as directed by Keystone standards
• Use measuring and testing devices according to established instructions or quality practice standards
• Use manufacturing and quality assurance specifications to determine acceptance and/or performance on all assemblies

Minimum Requirements/Qualifications 

• High school diploma or equivalent
• Excellent communication and attention to detail.
• Must be able to work in a manufacturing work cell and cleanroom environment
• Must be able to perform repetitive work for extended periods of time
• Extended hours, including weekends and holidays may be required to support the organizations objectives
• 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.
• Authorized to work in the US without sponsorship.

Physical Requirements                                             

• Must be able to read and write, and perform basic math
• Must be able to work with small items and hand tools
• Frequently pushing, pulling, and carrying up to 40 pounds may be required
• Standing, walking, bending and stooping at the waist/knees are required at various times