We are looking for a talented individual to join our dynamic Keystone Manufacturing team located in Kalamazoo, MI. A Med 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 associate will complete visual inspections, and other testing as required, to identify non-conformities in parallel with production.
A successful Med 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 multi task with minimum interruption to work progress.
Responsibilities and Activities
- Responsible for manufacture and assembly 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
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 vacation and holidays
- Educational Assistance
