JOB TITLE: NORTHEAST TERRITORY MANAGER

Organization: DiaPharma Group, Inc.    

Description:
Due to our continuing growth, the DiaPharma Group, an Ohio-based provider of hemostasis research and diagnostic products requires a sales representative to cover the Northeast region of the US.  Our products are utilized by industry, reference,
research and specialty hospital laboratories in the blood coagulation field.

Requirements include: 
BS/MS degree in Biochemistry required with strong communication and organizational skills.  Successful laboratory sales track record with recent hemostasis/coagulation instruments/reagents a must!  Competitive benefits package includes medical, dental and vision insurance coverage and a 401(k) plan. Extensive travel required within the seven state region.  If you meet the above requirements, please email your resume to employment@diapharma.com.

JOB TITLE: QUALITY SYSTEM AND COMPLIANCE MANAGER

Organization: DiaPharma Group, Inc.    

Description:
 
The Quality System and Compliance Manager will manage quality systems, processes, and procedures to assure product safety and quality by driving business alignment to correct industry requirements and business objectives by managing quality system design, controls, and continuous improvement.  

Accountable for assisting the Regulatory Affairs Manager to ensure/follow up/implement corrective actions that are raised by deviations, internal audit or regulatory inspection.

Manages Document Control, CA/PA, and Training processes and personnel.

Manages quality systems, processes and procedures to assure product quality and safety across the business.

Engages strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs).

Owns the development and maintenance of policies and procedures for departmental functions.

Influences site compliance to Quality Policy and Quality Management System procedures.
 
Influences participation in compliance to internal and external regulations.

Influences quality system metrics such as Corrective and Preventive Action, training metrics, completion and complaint resolution metrics.

Qualifications:
  1. Bachelor’s degree (or high school diploma/GED plus 4 years experience work experience).
  2. 3-5 years experience working in the medical device industry, specifically in Quality Assurance and/or Regulatory Affairs.
  3. 1 year of management experience.
  4. Demonstrated experience in the medical device industry and knowledge of quality system regulations.
  5. Demonstrated ability to develop & lead process implementation & improvement in a team environment.
  6. Experience with all of the following:
    • CAPA, complaints and risk management
    • Medical Device Industry Experience
    • Quality Assurance
    • Regulatory Affairs
    • Document Control
    • Training
    • Complaint Handling
    • Experience performing internal audits

  7. Demonstrated ability to successfully comprehend & carry out/execute actions.
  8. Effective oral and written communication skills.
  9. Analytical & problem-solving skills/root-cause analysis.
  10. Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.
  11. Ability to prioritize and drive multiple programs.
  12. Exceptional conflict-resolution skills.
  13. Ability to effectively communicate using English 
  14. Must be willing to take a drug test as part of the selection process
  15. Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background
  16. For US, must have unrestricted legal authorization to work in the United States
  17. Must be willing to work in Cincinnati, Ohio.
Preferred Qualifications:
  1. Prior experience using word processing, spreadsheet, and presentation software.
  2. Integrity:  Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others.
  3. Accepting constructive criticism and dealing calmly and effectively with high-stress situations.  This includes continuing to persevere and remaining calm in challenging or frustrating circumstances.
  4. External Focus:  Understanding customer needs, marketplace dynamics, industry trends, and the competitive landscape in the industry/function and considering the external impact of business activities and decisions on the external environment.
  5. Inclusiveness:  Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others.
  6. Clear thinker:  Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely.
If you meet the above requirements, please email your resume to employment@diapharma.com.
 
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