Shipping and Receiving Associate

Warehouse seeks shipping and receiving person.

Description/Job Summary

PLEASE DO NOT APPLY IF YOU DO NOT MEET THE FOLLOWING:

Perform QC and QA Receiving, final visual and physical inspections for Medical Device components and product

Follow production standards and EN ISO 13485 standards and Food and Drug Administration (FDA) regulations

If you'd like to be considered for this position, please answer all the screening questions. Only those who have completed screening questions (and have a professional resume) will be considered for an interview.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Experience working for a manufacturer

Inspect Receiving components, In-process and finished product for defects or imperfections to ensure conformance to specifications

Assist QA/QC department in the development of quality-related processes, standard operating procedures (SOPs), training materials, and documentation to ensure compliance with all federal regulations for the Medical Device manufacturing. Draft quality assurance policies and procedures, when needed

Follow sampling procedures and directions for recording and reporting quality data

Operate and perform inspection within the department policy and procedures

Work with Production MAS 90 system, (warehouse and release) system, and ensure that all pertinent components information is documented and recorded onto the system or into the Device History Records

Prepare for and conduct weekly department meetings, such as: NCR, CAPA, and ensure required tracking of Quarantined Materials

Ensure required tracking reports, Nonconformance and Deviations, are generated accurately and timely.

Support in Change Control Documentation and work effectively with all departments

Use a team-oriented approach and communicate concerns and issues to management

Perform duties assigned and with minimal supervision

Ensure all safety and security rules are strictly observed and any, incidents or injuries are promptly reported to management

Focus on continuous improvement, and consistently demonstrate good business judgment

Assign other duties as necessary

Supports and participates in audit preparation and inspections by certifying agencies and regulatory bodies, i.e. UL, Notified Body, and FDA

Required Skills

American Society for Quality (ASQ) certification desired

Experience with Lean Manufacturing and ISO preferred

Experience in Quality Systems Audits desired

Knowledge of safety and regulatory (OSHA) and or FDA, ISO 9000, 9001 or ISO 13485 helpful

Excellent written and oral communication skills with advanced knowledge of Microsoft Excel and Word

Knowledge in Warehouse Data Management System desired

Must be a team player, detail-oriented, and honest

Must have the ability to:

Multi-task, problem-solve, and prioritize in a fast-paced working environment

Utilize testing and inspection equipment, when necessary

Accuracy in record data with completeness

Lift/push/pull up to 50 lbs

Operate a forklift

Must have:

Relentless drive to achieve advancement and continuous improvement

A willingness to learn and/or adapt to new work methods

Good verbal and written communication skills

Required Experience

At least 3 year of experience as a Quality Inspector I

2-3 years hands-on in regulated FDA manufacturing role with specific quality guidelines/standards

Required Education

High School Diploma or GED or Associate degree