ISO 13485:2003 Certified - FDA Registered

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Medbio strives to provide premier contract manufacturing services to the medical and biotechnology industries. By leveraging the latest technology and production equipment, Medbio is able to provide innovative manufacturing solutions and maximize customer satisfaction. In addition to the constant bettering of our manufacturing operations, Medbio is dedicated to achieving the highest level of employee satisfaction. We achieve this by creating a work environment for our associates that encourages individual development, opportunity to share ideas and teamwork.

Interested in Working for Medbio?

View our job postings below and if you are interested in a career at Medbio, email us your resumé and cover letter.

Plastic Injection Lead Metrologist

Summary of Functions:

The Lead Metrologist supports Engineering activities at Medbio Inc, including Product/Process Qualification/Validations, engineering studies, product development reviews. The Lead Metrologist will be responsible for training Quality Technicians and Quality Inspectors in metrology practices. The Lead Metrologist will assist in identifying new metrology equipment needs and leading improvement teams to improve the process of measurement, data storage, and reporting. This person will also support others areas of the organization in the areas of calibration, and auditing activities, while adhering to relevant ISO and cGMP, and FDA regulatory requirements.

Major Duties and Responsibilities:

  • Support Engineering in drawing reviews for metrology-related concerns and/or identify any metrology-related equipment or fixturing needs
  • Assist Engineering in the planning and writing of protocols, and the execution where necessary
  • Works with Quality Engineering to develop and execute validation f new metrology equipment
  • Support Engineering on the prioritization and completion of qualification activities
  • Work with Engineering on Mold Qualification, Engineering Studies, Measurement System Analysis (Gage R&R), and other measurement-related activities
  • Support metrology activities for complex project launches with important deadlines
  • Develop robust layout plans for new parts, ensuring utilization of proper measurement tools
  • Train and develop Quality Technicians and Quality Inspectors on the proper and consistent use of metrology equipment
  • Develop robust layout plans for new parts, ensuring utilization of proper measurement tools
  • Train and develop Quality Technicians and Quality Inspectors on the proper and consistent use of metrology equipment
  • Develop and document relevant measurement procedures
  • Assist in the development/improvement of date-enabling systems
    • Data Collection
    • Data Storage
    • Programming File Management and Control
  • Serve as the backup person for monthly internal calibrations, and facilitate the scheduling, transportation, and return of all externally-calibrated devices
  • Learn and follow ISO/cGMP requirements, ensuring that the procedures and systems at Medbio are in compliance, and maintaining a high level of awareness of the requirements among the employees at Medbio
  • Interact with Management, Engineers, Maintenance, Supervisors, Team Leaders, Operators, and Customers, to resolve part- and process-related issues
  • Perform other tasks assigned by the Quality Manager or Vice President of QA/RA

Organizational Relationships:

The Lead Metrologist reports directly to the Quality Assurance Manager, Management, Supervisors, Team Leaders, and Technical Staffing can look to the Lead Metrologist for clear resolution to specification and/or part-quality issues. Engineering will regularly partner with the Lead Metrologist to assist with blue print interpretation, potential fixturing designs, and in problem resolution both internally and externally. The Lead Metrologist will work closely with the Quality Technicians and Inspectors as well as manufacturing in order to develop and improve metrology-related practices.

Experience and/or Educational Requirements:

  • Four-year degree or equivalent in years’ experience in Quality-related field is preferred
  • Five years or more involved in plastic injection molding is preferred
  • Five years or more experience in CMM and/or other software-operated metrology equipment
  • Experience in a medical device or pharmaceutical manufacturing environment is preferred
  • Solid understanding of ISO and FDA regulations and cGMP requirements
  • Good computer skills (Microsoft Office)
  • Strong communication and teamwork skills
  • Strong analytical skills
  • Excellent blueprint reading skills with strength in GD&T principles
  • Very strong written/verbal communication skills, leadership, interpersonal and motivational skills
  • Self-motivating and ability to manage the Lead Metrologist’s portion of complex projects with important deadlines

Physical Requirements:

Must be able to work a standard 40-hour work week with occasional overtime including, weekends as a possibility. Sitting and/or standing for an extended period of time as well as some walking within the facility. Must have 20/20 vision with or without corrective lenses and be able to distinguish color differences and depth perception for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 100 feet. Must be able to lift an carry various items up to 50 pounds.

Inside Sales/ Customer Service

Summary of Functions:

The Inside Sales/ Customer Service position will be responsible for inside sales, customer service, and marketing support. In addition, this position will support special projects for other departments as needed.

Major Duties and Responsibilities:

  • Responsible for entering and marketing SO process and order entry including contract review, order confirmation, order change process, customer returns, etc.
  • Provide customer-directed shipment requirements such as timing, quantities, destination, transportation method(s), special instructions and communication as necessary to Medbio staff and customers
  • Coordinate and execute customer mailings
  • Maintain customer database
  • Responsible for new customer searches (data mining) and initiating contact with prospects
  • Coordination of trade shows including but not limited to, booth accessories, freight logistics, preshow mailings, and post-show follow-up
  • Coordinate special projects for all departments as necessary
  • Responsible for confidentiality of financial, sales, and personnel data

Organizational Relationships:

Directly reports to the Direct of Sales and Marketing, with indirect reporting to the other managers. Needs to be a team player and work closely with the entire Medbio team.

Experience and/or Educational Requirements:

  • Advanced computer (Microsoft Suite and ERP-IQMS a plus)
  • Strong written and verbal communication skills
  • Must present self in a professional manner
  • Must have enthusiasm and possess excellent customer service skills
  • Able to multi-task and adjust between projects as needed
  • CRM Software experience helpful
  • Hours from 8:00am-5:00pm daily, with some overtime required
  • Previous inside sales and/or customer service experience a plus
  • Associate’s and/or Bachelor’s degree a plus

Physical Requirements:

Must be able to work and perform what would be considered standard practices for this type of positions in the industry.

Plastic Injection Molding Machine Operator – 2nd & 3rd Shift

Summary of Functions:

Responsible for part production; molding, assembly, and inspection of all product produced.  The selected candidate will have excellent vision, hand eye coordination, dexterity, and analytical skills with a high focus on organization, cleanliness, ability to follow procedures, and quality of work.

Major Duties and Responsibilities:

  • Able to retrieve product from molding machines; both automatic and manual at standard rates
  • Able to visually inspect and measure all parts according to specifications and blueprints
  • Able to perform assembly work at the standard rate and meet all quality expectations
  • Must follow all specifications, department procedures, and all ISO/GMP’s
  • Must be able to work as a team with other Operators and Support Staff
  • Must understand department goals and objectives as well as participate in advancing them

Organizational Relationships:

This position will directly report to the Molding Team Leader.  There will be frequent interaction with Technicians, and Quality personnel, as well as regular interactions with engineering.

Experience and/or Educational Requirements:

  • High School Diploma or equivalent
  • 2-5 years experience in fast paced environment of medical device molding and assembly
  • Strong communication and teamwork skills
  • Strong analytical skills
  • An orientation toward process improvements
  • Able to read and write fluently as well as read basic blueprints and dimensional callouts

Physical Requirements:

Must be able to work a standard 40-hour workweek with occasional overtime including weekends a possibility.  Sitting and/or standing for extended periods of time as well as some walking within the facility.  Must be able to see with or without corrective lenses and distinguish color differences and depth perception for product and safety issues.  Hearing ability should be sufficient to hear and react to audible alarms from distances up to 100 feet.  The ability to lift and carry various items up to 50 pounds.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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