How to Apply:

Interested candidates should send their resume, title(s) of job for which they wish to be considered, and salary requirements to recruiter@extendmystaff.com. ExtendMyStaff, Inc. partners with Origen to help hire top talent.  If you are selected to move forward in the process, you will be contacted by an ExtendMyStaff representative.  Unfortunately, due to the volume of candidates, it is not possible to follow-up with all applicants, but we invite you to visit OriGen’s Career Page often, as we are updating with new opportunities frequently.  We look forward to hearing from you.

Current Job Openings:

Client Accounts Representative

Position Summary:

The Client Accounts Representative is responsible for primary customer contact. They will be the first point of contact for customer service calls, emails, and fax; they must remain friendly and courteous at all times. Candidate is expected to develop an understanding of the product line and be able to quickly assist customer’s requests. A comprehensive understanding of OriGen Products is expected.

Essential Duties and Responsibilities:

The essential duties and responsibilities of this position include, but are not limited to the following:

  • The Client Accounts Representative will create new accounts, checking credit references, setting credit limits and terms.
  • Assist the customer with technical information on product usage and trouble shoot any issues that may arise for them.
  • Handle complaints and follow up with the customer at the completion of the complaint investigation to report their response to post market surveillance.
  • Candidate must have a friendly and courteous telephone persona, be able to take phone orders.
  • Accurately transfer all orders sent via fax, email or take over the phone to our ERP system and follow up with the logistics team in the Netherlands.
  • Coordinate with Production for any products requiring a lead time and communicate that to the customer.
  • Responsible for assisting customers with returns, and following up with Accounting to ensure that credit notes are sent or refunds issued.
  • Issue both verbal and written quotes as needed.
  • Liaise with the European Distribution Center to ensure that all information is handed off to them and it also correctly input into the ERP system.
  • Careful organization of work and timely responses are required.
  • Create a weekly report of sample shipments and follow up on customer satisfaction of samples received if out of USA and Canada.
  • Cross training with logistics on customer shipment and perform duties as needed/ assigned.
  • Other duties as assigned

Skill set:

  • Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
  • Knowledge and skill in using computer software and hardware applications, including Microsoft Word and Excel.
  • Outstanding communication skills, both written and oral, and will be expected to communicate directly with production management, production technicians, engineers, and senior management.

Competencies:

  • Results-driven
  • Technical Capacity
  • Ethical Conduct
  • Communication
  • Decision making
  • Interpersonal skills
  • Stress Management
  • Minimum Qualifications (Knowledge, Skills, and Abilities)
  • Bachelor’s degree in a science field
  • One year of customer service experience or equivalent
  • Strong ability to understand and interpret customer needs
  • Strong interpersonal and people skills
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Strong and effective communication skills (verbal and written)
  • Pays very close attention to detail
  • Ability to work independently and within a team environment on assigned projects from inception to completion

Preferred Qualifications:

  • Two years of related experience
  • Experience with Medical Devices or Regulatory environment

Supervisory Responsibility:

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Work Environment:

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands and Work Environment :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

Salary:

Commensurate with Experience.

QA Specialist I/II

Position Summary

The QA (Quality Assurance) Specialist I/II develops programs to support and implement the Quality Management System as developed for OriGen products and processes.  This includes creation of documents and reports on both product quality as well as the effectiveness of the Quality system. Working with the QA Manager (and/or RA/QA Director), they will create a system of continuous improvement for both products and quality reporting.  

Essential Functions

Quality activities include:

  • Write, revise, and approve documents and reports related to quality system activities.
  • Works to increase outgoing product quality
  • Works with suppliers to maintain and improve incoming material quality
  • Works with QA staff to maintain and increase competency and efficiency
  • Manage the Electronic QMS, and train others in its use
  • Assist with document control activities
  • Assist with risk assessment/ risk analysis
  • Performs corrective/preventive action planning and execution
  • Performs complaint investigation and trending
  • Conducts and supervises Internal Audits
  • Prepares for and participates in inspections/audits by external auditing organizations and customers
  • Assists with field actions including FSCAs and recalls
  • Assists in development of Management Review content

Competencies

  • Thorough knowledge of 21 CFR 820, ISO 13485:2016 and MDSAP requirements
  • Familiar with complaint handling, CAPA, Non-conforming material processes, including root cause analysis techniques
  • Familiar with using an eQMS system
  • Self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
  • Interpersonal skills necessary to work effectively in a team environment.
  • Works cross functionally to complete projects and testing.
  • Exercises judgment within broadly defined practices and policies.
  • Exceptional skills in using computer software and hardware applications, including Microsoft Word and Excel.
  • Outstanding communication skills, both written and oral, in communicating across the organization and outside of the organization

Required Education and Experience

  • Bachelor’s Degree or equivalent in life science or engineering field
  • Minimum of 3 years’ experience in medical device quality assurance discipline: knowledge of domestic and international medical device quality system regulations and standards

Preferred Education and Experience

  • Certified Internal Auditor (ASQ or similar program)
  • Experience in ERP and eQMS/eDMS systems

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Position Type and Expected Hours of Work

This is a full-time position.

Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m.  In some cases, additional work hours may be required.

Travel

5%

Work Environment

  • This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
  • This job periodically operates in a cleanroom environment.  Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.

Salary:

Commensurate with Experience.