Robling Medical Incorporated

Careers

Robling Medical, Inc. is currently searching for the following positions.  With a great culture and strong leadership, we are  making a positive difference in patients’ lives everyday.

Open Positions

The QA Specialist’s primary responsibility is to perform product inspection and to review device history records along with providing support and training to manufacturing personnel.  The QA Specialist will be required to provide guidance and oversight to manufacturing in the management, root cause analysis, corrective action and rework of nonconforming materials.  Other duties will include performing internal audits and providing support to calibration program, assisting with environmental testing, assisting with receiving inspection.

Position: Quality Assurance Specialist
Department: Quality Assurance
Reports to (Title): Quality Assurance Manager
Manages: 0 Direct Reports
FLSA Status: Non Exempt

General Summary

The QA Specialist’s primary responsibility is to perform product inspection and to review device history records along with providing support and training to manufacturing personnel.  The QA Specialist will be required to provide guidance and oversight to manufacturing in the management, root cause analysis, corrective action and rework of nonconforming materials.  Other duties will include performing internal audits and providing support to calibration program, assisting with environmental testing, assisting with receiving inspection.

Primary Duties and Responsibilities

  • Perform receiving inspection, in-process and/or final inspection of disposable medical devices, as well as electro-mechanical assemblies
  • Perform activities related to the documentation, control, disposition and root cause analysis of the non-conforming material
  • Provide guidance and oversight of manufacturing in the execution of rework activities
  • Write nonconforming material reports, rework instructions
  • Train manufacturing employees
  • Provide support to the QA Manager in the maintenance of the calibration program
  • Provide support to the QA Manager in the collection and maintenance of bioburden samples and data
  • Provide support to Quality Engineers in the testing and data collection during execution of validation activities
  • Perform inspections for proper machine set up
  • Conduct internal audits
  • Other Duties as assigned by the QA Manager

Required Qualifications

  • High school graduate
  • Strong attention to detail
  • Strong technical aptitude
  • Ability to read and understand mechanical drawings/ blueprints
  • Ability to understand ANSI Z1.4 sampling plans
  • Strong math skills                                                                            
  • Experience with various measuring equipment (i.e. ruler, caliper, micrometer, visual measuring equipment
  • Proficiency in development and maintenance of Microsoft Word documents and Excel spreadsheets
  • Excellent written communication
  • Excellent verbal communication skills
  • Strong leadership skills

Environment & Working Conditions

  • Lifting –  20 lbs
  • Standing for long periods of time
  • Bending
  • Sitting for long periods of time
  • Use of rulers, calipers/micrometers, height gage, tensile and compression testing equipment, pressure decay tester, burst tester,
  • Visual –  constant visual attention
  • Primary work environment in clean rooms where gowns and hair covers are required.

General Summary 

The EMS Technical Writer/Project Administrator is responsible for the research, organization and compilation of technical documentation for the company’s engineering and manufacturing projects. This person: 1) maintains proper methodology to ensure consistency, efficiency, accuracy, and compliance with company and ISO standards; 2) assists Engineers and Production Supervisors with the research and collection of technical documentation required for the preparation of company manufacturing documentation, 3) Leads the initiation, generation and maintenance of company manufacturing work instructions.  Leads the department in the generation of NMRs, material specifications, bills of material, work instructions, inspection forms, controlled artwork files, drawings and other documentation; and 4) assists Project Managers in keeping engineering project files and schedules current and accurate.

Primary Duties and Responsibilities

  • Supports multiple projects by ensuring manufacturing and engineering documentation is accurate, complete and current.
  • Conducts appropriate research related to documentation and projects.
  • Ensures all documentation is compliant with company requirements and standards.
  • Able to capture, modify and incorporate photos and images into assembly instruction.
  • Communicates with customers, vendors, employees, etc. regarding established technical specifications and to determine subject material to be developed.
  • Reviews published documentation and recommends revisions or changes in scope, format, context, etc. as needed.
  • Reviews drawings, specifications, mockups and product samples in order to generate work instructions that may include tooling/fixtures and other production sequences.
  • Observes the determined assembly processes in order to understand and determine the proper documenting of operation procedures and improvement efforts.
  • Organizes and formats documentation, which may include instructions, quality documents, drawings, specifications, data sheets, charts, graphs, etc.
  • Ensures all documentation and project files are accurate, complete and up to date and distributes as required.
  • Participates in special projects as required.

Required Qualifications

  • Minimum of 2 years’ experience in a technical writing field or technical engineering support role.
  • Advanced computer skills, especially Microsoft Office products (Word, Excel, PowerPoint, Project), Corel Draw, Acrobat Pro, Paint Shop, etc. Must be comfortable formatting drawings, technical data, etc.
  • Superior written and verbal communication skills.
  • Flexibility and the ability to interact with all levels of employees as well as customers and vendors.
  • Extremely thorough and accurate with a high attention to details.
  • Demonstrated technical aptitude.
  • Exceptional organizational skills.
  • Highly motivated and able to grasp complex software and learn quickly.
  • Ability to deliver high quality documentation.
  • Minimum 2-5 years’ experience in an ISO compliant manufacturing environment.
  • A sample of prior work must be submitted at interview.

Preferred Qualifications

  • Associates degree in Technical Writing, an Engineering field of study or similar technical discipline.
  • Medical device or pharmaceutical experience.

Environment & Working Conditions

  • Sitting for long periods of time.
  • Visual – constant visual attention.

General Summary

The Material Handler loads, unloads and stages products, parts and other supplies.  This role requires the team member to have strength and stamina to cope with the physical requirements listed below.  The Material Handler should: follow standard operating procedures and possess knowledge and understanding of material and stock management along with inventory control methods. Products going out must be packaged and/or wrapped to ensure damage-free delivery. 

Primary Duties and Responsibilities

  • Observes all safety procedures, regulations, and rules
  • Pulls inventory based on specific customer service order requirements (accuracy of pulling correct item, lot number and quantity is imperative)
  • Verification of product expiration date to customer approved requirements is critical
  • Verification of count of items pulled is critical.
  • Loads, unloads and moves products, parts and other supplies as needed
  • Enters production shipments into FedEx and UPS Shipping Software systems
  • Ensures the cleanliness and proper stocking of inventory in the warehouse
  • Works to ensure cleanliness and quality in the warehouse and helps track all damaged inventory, reporting this information to the Warehouse Team Leader
  • Ensures proper packing, labeling and tagging of the inventory
  • Ensures proper operation of warehouse equipment, including forklifts, packaging machines, etc.
  • Ensures inventory is organized, properly labeled and can be easily located

Required Qualifications

  • Previous experience working in a warehouse
  • Computer proficiency, including previous experience using FedEx and UPS Shipping Software systems
  • Forklift experience
  • Strong multi-tasking skills
  • Good knowledge of use and operation of warehouse machinery and equipment
  • Strong team player
  • Must meet all physical requirements
  • Good time management skills in order to meet deadlines
  • Follows all safety guidelines
  • Able to work overtime as needed and flexibility in schedule
  • Good math skills and be good with numbers (Must pass a math test)
  • Must be self-motivated and demonstrate the ability to effectively and efficiently perform the job
  • Good verbal and written communication skills
  • Excellent interpersonal skills

Preferred Qualifications

  • Forklift driver certification or experience.

Travel Requirements

This position requires 0% travel on average.

Physical Requirements

  • Must have the ability to stand, climb, bend, and lift products and materials of up to 80 pounds for extended periods of time
  • Will stand for long periods of time
  • Must be able to drive a forklift and use packaging machines and any other tools or equipment in the warehouse
  • Visual – must be able to read and understand labels and other shipping and receiving information. Must meet the stated vision requirements of 20/30 (with or without corrective lens must pass an exam) and pass the color-blindness test.

Environment & Working Conditions

This position is generally performed indoors in a warehouse or plant environment.  When the warehouse doors are open for shipping or receiving, employee could be subject to the heat or cold outside. 

General Summary

Leads Human Resources practices and objectives that will provide an employee-oriented, high performance culture that emphasizes empowerment, quality, productivity and standards, goal attainment, and the recruitment and ongoing development of a superior workforce.  Plans, directs and coordinates human resource activities to maximize the strategic use of human resources and to maintain the full scope of human resource functions.  Assesses and anticipates Human Resources needs. This position reports to the Vice President.

Primary Duties and Responsibilities

  • Manages employment and recruitment activities, on-boarding process, employee retention and terminations
  • Coordinates with temporary services providers for variable staffing needs
  • Manages and monitors performance management
  • Coordinates and communicates safety program, including OSHA reporting
  • Manages employee relations, including recognition program and other activities
  • Analyzes training needs to ensure employee development
  • Ensures compliance with legal requirements and serves as HIPAA, ADA, AAP, and EEOC coordinator
  • Coordinates with benefit providers for annual renewal of benefit programs
  • Administers employee benefits program
  • Maintains health and wellness strategy for employees
  • Creates and distributes employee communications
  • Administers discipline and assists in managing disputes including conducting internal investigations
  • Partners and consults with managers on organizational policies, such as equal employment opportunity, sexual harassment, discrimination, etc. and makes recommendations as appropriate
  • Maintains employee records and confidentiality and compiles reports concerning personnel data
  • Develops and communicates company policies and procedures
  • Processes payroll for temporary and permanent employees

Required Qualifications

  • Bachelor’s degree
  • Requires at least 8 years progressive human resources generalist experience
  • Hands-on responsibility for full scope of HR activities, including strategy, analysis and operations
  • Excellent verbal and written communication skills
  • Excellent organizational and planning skills
  • Knowledge and ability to apply HR laws and regulations
  • Proficiency in Microsoft Office products
  • Highly effective with diverse groups

Preferred Qualifications

  • Advanced degree
  • Professional certification (PHR or SPHR)
  • Supervisory experience

 

Travel Requirements

This position requires 0 % to 5% travel on average, including the possibility of overnight travel; this might require travel by air and/or international travel.

Environment & Working Conditions

This position is generally performed indoors in an office or plant environment but may include some time in field settings.  As a salaried exempt position, the role requires the willingness and dedication to invest the time required to get the job done, which may include working more than 40 hours per week.

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