Manufacturing Operator II #JN -052021-64217

Description:

• We are looking for a new round of candidates, as all previous submittals have been reviewed.
• Perform production line duties required to meet production goals while complying with quality standards and safety requirements.
• Operate production equipment and complete documentation in accordance with cGMPs and department SOP’s while monitoring product to ensure quality standards are maintained.

Essential Duties and Responsibilities include the following (other duties may be assigned.):

• Performs electro-mechanical assembly of final products, sub-assemblies and related medical device products by following released procedures.
• Ability to use small hand tools including electric and manual screwdrivers, torque wrenches, pliers, tweezers, and scanners.
• Employs high standards of workmanship to ensure high quality products are produced on schedule. Typically works on assignments under the guidance of a senior assembler or lead.
• Must be able to work in a team-oriented atmosphere with assemblers, technicians, QA personnel, and engineers, completing tasks and communicating effectively, both orally and in writing.
• Performs in-process inspection to ensure products meet specifications and standards.
• Must be able to read and understand assembly instructions, production orders, Bills of Materials, Standard Operation Procedures, and all other documentation used to control the products and processes.
• Collaborates with peers to achieve shared departmental goals.
• Fills out time sheets and all other required paperwork accurately and on time.
• Maintain a clean and organized work area during and at the end of each shift.
• Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.
• Perform all assigned duties according to departmental SOP’, Work Instructions, DHR’s and cGMP’s.
• Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department.
• Complete and remain current with all required cGMP and safety training.
• Perform tasks in the production / packaging of product to provide on-time delivery to customers.
• Complete all required documentation associated with the production and / or packaging of product.
• Perform other duties as assigned.
• May be cross trained to other product lines as needed.
• Will assist with new product validations and work instruction evaluation builds
• Flexibility when overtime as requested by the supervisor. This may include nights, weekends, and holidays during times critical to our business such as month-end, quarter-end, and year-end

Qualifications:

• High school degree or equivalent.
• 1 year of manufacturing and/or medical device assembly experience is preferred but not required.
• Previous experience in the medical device field and GMP regulated environment is preferred.
• Detail-oriented and self-motivated.
• Strong mechanical skills needed for equipment builds and repairs.
• Excellent hand-eye coordination and manual dexterity.
• Excellent math skills; ability to add, subtract, multiply, and divide.
• Ability to read, comprehend, write, and communicate effectively in English.
• Ability to carry out detailed written or verbal instructions.
• Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
• Basic user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems.
• Ability to work any shift (up to 12-hours) as required dependent on business needs.
• Physically able to continuously stand and walk.
• Physically able to lift up 25 pounds.
• Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently.
• Ability to adapt to changing priorities quickly and efficiently.
• Ability to use, clean, and store tools and other devices required for the performance of the job in a manner which prevents damage to the tools and / or equipment.