1st shift Operator I (Monday-Friday 7:00 am-3:00 pm)

Job Description

Job Description

What we are looking for:

The Operator performs assembly, runs manufacturing lines, label printing functions, and/or packaging tasks in accordance with applicable Work Instructions (WI), Visual Inspection Criteria, Standard Operating Procedures (SOP), and internal specifications in an FDA regulated environment. There are four (4) levels within this position, defined by the Operator Career Ladder. The incumbent is assigned to workstations based on successful completion of training and may be primarily assigned to one area or functional task.

1st Shift: Monday-Friday 7:00 am-3:00 pm

What you will do:

• Follows Standard Operating Procedures (SOP) and Work Instructions (WI’s) to manufacture and package components of medical devices.
• Performs assembly, machine operation, label printing, and packaging as required. May be cross trained in multiple areas or focus in a primary area.
• Performs responsibility in accordance with production standards and rates while adhering to quality requirements.
• Conducts in-process inspection and testing of material to ensure it meets criteria, elevating to management and documenting/reporting defects into the production records. May require measuring and simple mathematical calculations to ensure product meets specification requirements.
• Labels and packages product as per internal specifications.
• Performs leak-testing and operates pouch sealing equipment according to product work instructions and company procedures.
• Maintains clean machinery, parts, and surrounding area.
• Completes all paperwork associated with daily tasks.  Carries out job requirements and operates equipment within safety guidelines and reports any nonconformance.
• May perform Inventory/cycle counts

Who you are:

• High school graduate or equivalent.
• Ability to effectively communicate with coworkers and management. Business communication is conducted in English.
• Ability to comprehend and follow SOP’s, WI’s, policies, and procedures such a safety, quality, and HR that are written in English.
• Possess basic mathematical skills to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Basic understanding of Good Manufacturing Practices (GMP) and working within FDA regulated industries preferred.
• Basic computer skills including ability to use MS Outlook and automated manufacturing and quality systems. 
• Excellent interpersonal skills with ability to get along well with others and work in a team environment.
• Ability to properly complete paperwork as required according to work instructions, standards, or other specifications.
• Excellent dependability and reliability
• Willingness to accept change, learn, and work with new processes
• Familiarity with an ERP system and Quality Management System (eQMS) preferred
• Must be able to work extended hours when required
• 20/20 vision (with corrective eyeglasses) and ability to pass a color perception test.

Perks / Benefits:

• Generous Paid Time Off
• Paid Breaks
• Annual Bonus
• 401(K) with excellent company match
• Health Insurance with multiple plans to choose from
• Paid Short Term and Long Term Disability