Mfg Lead Operator

Essential Responsibilities This position will be responsible for ensuring that manufacturing of items by team members are carried out efficiently and with strict adherence to quality standards. To operate manually and/or automated machinery to produce and assemble quality products. Safely performs the manufacturing, packaging, and labeling processes used in the Clean Room environment to ensure quality products are shipped on time to our customers.  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 a 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, Work Orders, 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 and enforce all established safety, health, quality GMPs and all applicable SOPs Performs other duties as assigned based on business needs Supervisory Responsibility This position is an individual contributor and has no direct supervisory responsibility.

  Work Environment This position operates in an office and manufacturing environment.  This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.  The position also interacts with machinery on the manufacturing floor and numerous devices that are sold by the company.   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.  While performing the duties of this job, the employee is regularly required to talk or hear.

The employee frequently is required to stand, walk, and stoop; use hands to finger, handle or feel; and reach with hands and arms.  The employee frequently is required to lift and/or carry up to 20 pounds.  For more information, please refer to the Position Analysis/Physical Activities Checklist on file in Human Resources.   Position Type and Expected Hours of Work This is a full-time position.

Days and hours of work are Monday through Thursday, 5:00 a.m. to 4:00 p.m. Occasional evening and weekend work may be required as job duties demand.   Travel This position requires no measurable travel.   Required Education and Experience High School Diploma or equivalency 1+ year’s Lead Operator experience in manufacturing or equivalent experience preferred Working knowledge of Microsoft Office applications MRP/ERP experience preferred 3+ years of clean room experience 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 Medical device industry or regulated industry experience preferred   Position Requirements Excellent verbal and written communication skills Must be dependable, reliable and have a good work ethic Detail oriented – quality and precision focused Team collaboration and development skills Abilit to produce high quality work in a high-volume environment Ability to remain flexible and open to change within a fluid global industry &n