Primary Responsibilities:

• 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.

Other Duties

• Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOP’s, Work Instructions) to successfully accomplish job requirements.
• Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.
• Follows gowning procedures in designated areas.
• Follows established safety requirements and adheres to the Health Safety and Environment Management System.
• Performs other job-related responsibilities as assigned.

Physical Requirements:

• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Ability to stand frequently
• Ability to sit often
• Ability walk and/or move around in a controlled environment occasionally
• Ability to use hands to grasp and perform fine manipulation frequently
• Ability to stretch/reach with hands and arms frequently
• Ability to lift arms overheard occasionally
• Ability to climb or balance occasionally
• Ability to stoop, kneel, crouch, or crawl occasionally
• Ability to talk or hear frequently
• Ability to lift up to 50lbs occasionally
• Ability to push and/or pull occasionally
• Ability to handle chemicals and/or lab work often

Qualifications:

• 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

Competencies:

• Machine Operation: Operate and supervise one or a group of machines for the manufacture, processing or packaging of products.
• Manual Dexterity: Perform manual movements and activities associated with occupied positions.
• Attention to Detail: Taking responsibility for a thorough and detailed method of working.
• Work Ethics and Values: Demonstrating and supporting the organization's ethics and values.
• Achievement Orientation: Being persistent and showing perseverance on achieving concrete and tangible results out of personal responsibility; getting optimum results from situations; being ready to take action and show tenacity in case of obstacles or resistance.

 

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