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.

Controller

Summary of Functions:

The Controller is responsible for cash management, is the key contact person for audits, advises Senior Accountant with regards to monthly and annual accounting routines as required, along with support of special projects.

Major Duties and Responsibilities:

  • Ultimately responsible for overseeing the department
  • Ensure the timely and accurate month end/year end close
  • Cash Management
  • Personal Property Taxes/ ESA and all Tax related stuff
  • Government Reporting
  • Budget Labor and give direction to department on budget development
  • PIT
  • Develop a financial package for non-financial managers that can be useful for managing their areas
  • Review monthly numbers with managers
  • Responsible for activities necessary for month-end close in a timely manner
  • Oversee Account analysis and financial reporting
  • Provide charts for Strategic Group
  • Provide support for year-end close
  • Responsible for confidentiality of financial information, personnel information, etc., other than to Senior Management
  • Provides support on projects for management
  • Perform any other related duties as requested by supervisor

Organizational Relationships:

The Controller reports to the Director of Corporate Finance. This position has a working relationship with the management team and all functional areas of the company.

Experience and/or Educational Requirements:

  • Minimum of a Bachelor’s degree in Accounting and 10+ years of experience or equivalent
  • Experience in accounting within a manufacturing environment
  • Ability to communicate effectively with people at all levels throughout the organization
  • Strong analytical skills
  • Good oral and written communication skills
  • Ability to meet deadlines
  • Have self-initiative
  • Excellent planning, organizational, coordination, and time management skills
  • Software/Excel strength required

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 Senior Quality Engineer

Summary of Functions:

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

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.
  • Manage Customer Complaints and Supplier Corrective Action Requests (SCARs) from assigned customers and record them in their respective logs. The Sr. QE will work with others in the organization to drive toward root-cause identification and solid, well-documented actions to prevent recurrence.
  • Assist Engineering with support for new product developments, including drawing reviews, Measurement System Analysis, and representation in customer meetings/design reviews, related to assigned customers.
  • Assist Engineering in the planning and writing of protocols, and the execution (i.e. evaluation of parts) where necessary. The Sr. QE will have responsibility for approving protocols.
  • 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, particularly for assigned customers.
  • Review all Mold Qualification results, for dimensional results and/or general paperwork submissions to assigned customers.
  • Review production documentation and ensure completeness and accuracy, and compliance of the production records to the SOPs. The Sr. QE will have responsibility for approving specification releases (DCNs) related to assigned customers. 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 Director of Quality Assurance for the review and sign-off of Protocols and Reports, as well as for DCNs, Temporary Deviations, and other related authorizations.

Organizational Relationships:

The Sr. QE reports directly to the Director 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 and/or a minimum of 10 years’ experience in a Quality-related field
  • Two years or more involved in plastic injection molding
  • Preferred experience in a medical device manufacturing environment
  • Solid understanding of ISO/FDA requirements with regard to manufacturing and document control
  • Strong computer skills (Microsoft Office, MiniTab preferred)
  • Excellent blueprint reading skills, and proven understanding of GD&T
  • Very strong written/verbal communication, leadership, interpersonal, and motivational skills
  • Self-motivation and ability to manage the Sr. 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 Machine Operator — 2nd & 3rd Shifts

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 Shift Supervisor. There will be frequent interaction with Technicians, and Quality personnel, as well as regular interactions with engineering.

Experience and/or Educational Requirements:

  • 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.

Innovative.  Trustworthy.  Knowledgeable.  Passionate.
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