Mfg Lead Operator

Job TitleThis 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.Essential Responsibilities:Operate, inspect, and troubleshoot production line machinery and/or assembliesFollow documented work instructions, monitor materials, assemble products, and visually inspect parts to quality specificationsAssure accuracy of product packaging and tractabilityLoad/unload items from machines, carts, and dolliesRead and maintain accurate recordsMaintain a clean and organized work areaUphold safety and quality assurance standardsDetect quality defects in partsContinuously provide supervisor with suggestions to improve equipment, tools, and processesPack and label acceptable product to specificationsAccurately complete Device History Records, Work Orders, and associated paperworkCommunicate effectively and positively with coworkers and staffUtilize small hand tools and/or precision devices to aid in the manufacturing processFollow and enforce all established safety, health, quality GMPs and all applicable SOPsPerforms other duties as assigned based on business needsSupervisory 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 equivalency1+ year's Lead Operator experience in manufacturing or equivalent experience preferredWorking knowledge of Microsoft Office applicationsMRP/ERP experience preferred3+ years of clean room experienceExperience following work instructions, process documentation, and procedures to ensure safe working conditionsA 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 accuracyDemonstrated communication and interpersonal skillsExcellent decision-making and problem-solving skillsStrong organizational skillsMedical device industry or regulated industry experience preferredPosition Requirements:Excellent verbal and written communication skillsMust be dependable, reliable and have a good work ethicDetail oriented – quality and precision focusedTeam collaboration and development skillsAbility to produce high quality work in a high-volume environmentAbility to remain flexible and open to change within a fluid global industryCompetencies:Problem Solving/AnalysisResults DrivenDetail OrientationCustomer FocusTechnical CapacityCommunication ProficiencyAdditional Eligibility Qualifications:None required for this position.Work Authorization/Security Clearance: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.AAP/EEO Statement:Erbe employees and applicants for employment are protected by federal laws, Presidential Executive Orders, and state and local laws designed to protect employees and job applicants from discrimination on the bases of race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service or other non-merit-based factors.

These protections extend to all management practices and decisions, including recruitment and hiring practices, appraisal systems, promotions, and training and career development programs.Other Duties:Please note this position description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.At-Will Employment:This position description does not constitute a contract or guarantee employment for any specified time. The company may exercise its employment-at-will rights at any time.Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.