ISO 13485:2016 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, while providing opportunities to share ideas and cultivate 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 Molding Quality Engineer

Summary of Functions:

The Quality Engineer (QE) primarily supports the customers to field any complaints or corrective action requests, and supports Engineering activities at Medbio. The QE will assist in, as necessary, production, metrology, and auditing activities, while preserving relevant ISO/cGMP requirements.

Major Duties and Responsibilities:

  • Learn and follow ISO/FDA requirements, ensuring that the procedures and systems at Medbio are in compliance; help maintain a high level of awareness of the requirements among the employees at Medbio
  • Field any Customer Complaints and Supplier Corrective Action Request (SCARs), and record them in their respective Logs. The QE will work with others in the organization to drive toward root-cause identification and solid, well-documented actions to prevent recurrence
  • Assist Engineering in the planning and writing of protocols, and the execution (i.e. evaluation of parts) where necessary
  • Assist Engineering in the brainstorming and recording portions of the risk analysis process, including Decision Tree Matrix (for protocols), PFMEA, Process Flow, Control Plans (when requested by the customer), and maintenance of any existing PFMEAs
  • Review production documentation and ensure completeness and accuracy, and compliance of the production records to the SOPs. Assist in writing Communication Travelers, as necessary, to clarify or enhance the production specifications
  • Create MRBs, as necessary, and assist in the investigations and disposition of suspect material, whether from internal or external sources
  • Provide input to all QA-related IQMS procedures and qualification efforts; provide necessary training and training literature for new modules
  • Provide backup support to the V.P. for the review and sign-off of Protocols and Reports, as well as for DCNs, Temporary Deviations, and other related authorizations
  • Assist the V.P. in the review of Mold Qualification results, for dimensional results and/or general paperwork submissions to customers

Organizational Relationships: 

The QE reports directly to the V.P. of Quality Assurance and Regulatory Affairs. Management and technical staffing can look to the QE for clear resolution to specification and/or part-quality issues. Engineering will regularly partner with the QE for measurement systems analysis, risk analysis, or qualification activities.

Experience and/or Educational Requirements:

  • Four-year degree or equivalent in years’ experience in Quality-related field
  • Two years or more involved in plastic injection molding
  • Preferred experience in a medical device manufacturing environment
  • Understanding of ISO/FDA requirements with regard to manufacturing and document control
  • Good computer skills (Microsoft Office)
  • Good blueprint reading skills; GD&T experience a plus
  • Very strong written/verbal communication, leadership, interpersonal and motivational skills
  • Self-motivation and ability to manage the QE’s portion of complex projects with important deadlines

Physical Requirements:

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

Plastic Injection Molding Process Technician – 2nd & 3rd Shift

Summary of Functions:

The Process Technician will support the production efforts at Medbio, Inc. in the staging of tooling and startup of production jobs while maintaining reasonable efficiencies, minimizing tool damage/wear, and preserving the safety of all viability. Support of engineering development and corrective/preventative action efforts are required as necessary.

Major Duties and Responsibilities:

  • Provide machine set up and process support for all production processes
  • Clean, stage and tear down molds (with extreme care and attention) to meet production needs
  • Communicate in an effective and timely manner any equipment issues/breakdowns to maintenance
  • Communicate in an effective and timely manner any tooling issues to the Production/Engineering Manager
  • Measure first shots for each production job, as necessary
  • Run sample parts and facilitate in establishing processes for new and transfer tooling projects
  • Exhibit safety awareness and safe work practices

Organizational Relationships: 

The Process Technician reports directly to the Process Engineering Manager, with a “dotted-line” responsibility to the Production Manager and the Engineering Manager. Production Supervisors will provide the scheduling priorities for the Process Technician and engineering samples or prototype runs will be scheduled in conjunction with the Engineering Manager and the Production Manager to avoid complications. 

Experience and/or Educational Requirements:

  • High School Diploma or GED equivalent. Prefer a two-year training certificate or Associates Degree in plastics-related subject
  • Attended advanced training courses in plastics injection molding processing
  • Preferred 5-10 years experience with advanced plastics injection molding processing
  • General understating of automation systems and equipment
  • Basic computer skills (Microsoft Office)
  • Basic blueprint reading skills
  • Strong written/verbal communication, leadership, interpersonal and motivational skills
  • Understanding of ISO and FDA/GMP regulations with regard to production processes and documentation practices

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 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 lift and carry various items up to 70 pounds. 

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.

Plastic Injection Molding Shift Supervisor – 2nd & 3rd Shift

Summary of Functions:

Responsible for planning, organizing, work direction, staff, continuous improvement and meeting all relevant key metrics for the department.

Major Duties and Responsibilities:

  • Plan, organize and direct staff to produce the required quality and quantity of products on all shifts
  • Work with the schedule and prioritize jobs to adhere to due dates
  • Maintain a clean, organized, uncluttered work area
  • Provide work direction to production team members (Operators, Quality Inspectors, Technicians, etc.) and hold accountable for performance
  • Assure all personnel are properly trained for tasks assigned and training documentation is completed and maintained
  • Perform all IQMS functions related to production and have a thorough understanding of the transactions. (Material flow, tracking, and movement, scanning, reports, data accuracy, reporting, monitoring, recognizing incorrect data, etc.…).
  • Maintain production system error free (IQMS and documentation)
  • Use Data to analyze and solve problems in the areas of production issues and material issues
  • Communicate and coordinate with all shifts and departments for smooth work transfer
  • Responsible for production performance and meeting established key performance indicators
  • Responsible for operating within established budget
  • Initiate improvement projects that are in-line with company objectives and document progress
  • Provide regular performance feedback and relevant communication to staff
  • Ensure ISO, FDA, and GMPs are followed
  • Work with Engineering to establish standardized processes with current and new jobs
  • Ability to perform quality checks when needed
  • Perform any other related duties as requested to ensure mini-company meets deadlines (load hoppers, schedule Operators, etc.)

Organizational Relationships:

Directly reports to the Production Manager. Will work with all other departments and will have some customer interaction.

Experience and/or Educational Requirements:

  • College degree and/or industry certifications or equivalent experience
  • Excellent written and verbal communication skills
  • Able to work well with people (team player) and processes
  • Highly organized and detail-oriented
  • May require flexible hours from time to time (possible overtime and weekends) to assure production schedules are met and off shifts are properly supported
  • Good understanding of ISO, FDA, OSHA/MIOSHA regulations and GMPs
  • Good understanding of ERP systems, preferably IQMS
  • Good working knowledge of Microsoft Office
  • Must have strong analytical skills
  • Medical manufacturing experience a plus

Physical Requirements:

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

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