Manufacturing Operator II
About The Position
This position will be responsible to operate manually and/or automated machinery to produce and assemble quality products. The role involves safely performing manufacturing, packaging, and labeling processes within a Clean Room environment to ensure timely shipment of quality products to customers. This is an individual contributor role with no direct supervisory responsibility. The work environment includes both office and manufacturing settings, utilizing standard office equipment like computers, phones, photocopiers, filing cabinets, and fax machines, as well as interacting with manufacturing floor machinery and company products.
Requirements
- High School Diploma or equivalency
- 0-3 years of clean room experience in a regulated Industry
- Experience following work instructions, process documentation, and procedures to ensure safe working conditions
- A team-driven attitude to work together and support department initiatives such as 5S and Total Productive Maintenance Systems (TPM)
- The ability to complete production paperwork, which includes inventory accuracy
- Demonstrated communication and interpersonal skills
- Excellent decision-making and problem-solving skills
- Strong organizational skills
- Excellent verbal and written communications required
- Detail oriented – quality and precision focused
- Team oriented
- Must be detail-oriented and produce high quality work in a high-volume environment
- Ability to remain flexible and open to change within a fluid global industry
- English and Spanish language proficiency candidates welcome
- Employees must be legally authorized to work in the United States
- Employees must not be specifically barred from working with Federal contracts, government entities or otherwise listed on excluded parties list as maintained by the Federal government
Nice To Haves
- Medical device industry or regulated industry experience preferred
Responsibilities
- Operate, inspect, and troubleshoot production line machinery and/or assemblies
- Follow documented work instructions, monitor materials, assemble products, and visually inspect parts to quality specifications
- Assure accuracy of product packaging and tractability
- Load/unload items from machines, carts, and dollies
- Read and maintain accurate records
- Maintain clean and organized work area
- Uphold safety and quality assurance standards
- Detect quality defects in parts
- Continuously provide supervisor with suggestions to improve equipment, tools, and processes
- Pack and label acceptable product to specifications
- Accurately complete Device History Records and associated paperwork
- Communicate effectively and positively with coworkers and staff
- Utilize small hand tools and/or precision devices to aid in the manufacturing process
- Follow all applicable SOPs and GMPs
- Demonstrate a mastery of product line stations at a high level of accuracy and efficiency
- Performs other duties as assigned based on business needs
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
11-50 employees
