ChoiceSpine is a privately held medical device company based in Knoxville, TN, and a leading designer, manufacturer, and distributor of specialized spinal implants, instrumentation, and biologics for the surgical treatment of complex spinal disorders. ChoiceSpine has been named a Top Knoxville Workplace for three consecutive years. We offer a competitive salary, comprehensive benefits (including company-paid Life/STD/LTD), 401(k), paid vacation and holidays, and an excellent work environment.

As a member of the Logistics team, you will be assisting in the incoming and outgoing distribution of products to our customers. This position requires a highly detail-oriented candidate with the abilities to multi-task, take initiative, and utilize strong organizational skills while communicating with the team.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Pick product orders accurately in a fast-paced environment.
• Perform processes of receiving, bulk packing and organizing parts in accordance with department Standard Operating Procedures.
• Organize materials with a limited shelf life or expiration dates using First In First Out.
• Perform daily cycle counts and help resolve discrepancies.
• Pull, audit, pack and ship orders using FedEx and UPS.
• Receive surgical sets and associated inventory from hospitals and distributors.
• Wash instrumentation as per ChoiceSpine procedures.
• Reconcile and replenish sets as per the Bill of Materials.
• Ensure set instrumentation and implants function properly and are aesthetically presentable.
• Utilize labeling software to fulfill internal labeling and re-labeling requirements.
• Follow housekeeping procedures which include but are not limited to; keeping personal workstation clean and organized; returning tools to proper locations; and organizing storage areas.
• Follows departmental safety policies and procedures and reports safety issues and concerns immediately.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.
• Shift hours are 10:00am to 7:00pm EST.

SUPERVISORY RESPONSIBILITIES

Not applicable

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Excellent organizational skills and meticulous attention to detail
• Excellent communication skills, both verbal and written
• Basic computer skills required (Word, Excel, Outlook)
• Must have excellent problem-solving skills
• Ability to work collaboratively with team
• Experience in Sterile Processing is a plus

EDUCATION and EXPERIENCE

High school diploma or equivalent and experience in warehouse or hospital environment preferred.

EXEMPTION

Non-Exempt

PHYSICAL DEMANDS 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to handle or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds with help if needed. Must be able to visually inspect small parts.

WORK ENVIRONMENT 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Working environment is typical of an office, manufacturing, and laboratory environment. Working in this environment may require the use of safety equipment, including but not limited to eye safety glasses, hearing protectors, and gloves.

SUMMARY

Under minimal supervision from the Quality Manager, the Senior Quality Engineer will support Engineering and Quality Assurance activities and assist Quality Control and Regulatory as part of a comprehensive Quality Management System.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Read and conform to all company policies and procedures.

• Interact and communicate with internal departments, including Purchasing, Shipping / Receiving, Engineering, Customer Service, and Sales/Marketing.

• Authority to place product on hold.

• Involved with new product development (NPD) process and the support of existing and previously commercialized products.

• Review and approve engineering drawings and assist in determining Critical-To-Quality Dimensions.

• Create, Review, and Approve Inspection Plans and Inspection tools as required.

• Create and Support validations for new and existing products and processes, including packaging and sterilization.

• Create and Support IQ, OQ, and PQ activities for equipment and additive implants.

• Perform and support Gage Repeatability and Reproducibility (Gage R & R) studies.

• Perform and support First Article Inspection / Inspections on Prototypes.

• Perform Statistical rationales as required.

• Support supplier quality management activities, including qualification, evaluation, and investigations.

• Support Post Market Surveillance activities.

• Support Complaint/NC/CAPA teams through the identification and development of corrective action plans, verification, and closure.

• Perform and support Design and Process FMEA activities.

• Collect, analyze, and summarize data and make recommendations as required.

• Support and prepare for site-level internal, external, supplier, and customer audits.

• Provide quality support to identify and resolve quality issues to ensure safe and effective medical devices.

• Interact and coordinate activities with other departments, support, and customers.

• Identify and implement opportunities for continuous improvement.

• Create and update Quality System Procedures and Instructions when applicable.

• Supports Quality, Engineering, and Regulatory to meet company and department objectives.

• Other duties as assigned by management

SUPERVISORY RESPONSIBILITIES

Not Applicable

QUALIFICATIONS

• Excellent communication skills and the ability to work with people at all levels.
• Ability to work independently and in a team environment.
• Strong organizational skills, attention to detail, self-motivator, ability to multi-task and meet timelines.
• A working knowledge of desktop computer office software and e-mail is required.
• Understand calibration fundamentals.
• Experience using inspection equipment such as calipers, micrometers, height gauges, plug and ring thread gauges, and pin gauges. Optical comparator and Vision system experience preferred.
• Understanding of SOLIDWORKS or 3D modeling is preferred.
• Knowledge and understanding of Medical Device Regulations / Certifications such as 21CFR820 & ISO13485:2016.
• Medical Device experience is preferred.

EDUCATION and/or EXPERIENCE

Engineering degree or equivalent and at least 8 years’ experience with mechanical inspection of precision machined products, medical device industry experience preferred

CERTIFICATES, LICENSES, REGISTRATIONS

Not Applicable

EXEMPTION

Exempt

PHYSICAL DEMANDS 

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. In addition, the employee should be able to stand, walk, use hands to finger, handle, or feel and reach with hands and arms. In addition, the employee must occasionally lift and move up to 25 pounds.

WORK ENVIRONMENT 

The work environment characteristics described here represent those an employee encounter while performing this job’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. The working environment is typical of an office environment. The noise level in the work environment is usually moderate.