Diapharma is currently hiring for:

QUALITY ASSURANCE / REGULATORY AFFAIRS (QA/RA) MANAGER

diapharma chromogenic clotting elisa assay test kit

Diapharma Group, Inc.

Job Description

QUALITY ASSURANCE / REGULATORY AFFAIRS (QA/RA) MANAGER

About Diapharma:

Diapharma Group, Inc. sells analyzers, kits, bioreagents, and chromogenic substrates for research and clinical applications in the fields of Coagulation, Bleeding Disorders, Cell Death, Toxicology, and Environmental Toxicology.

Diapharma Group, Inc. provides strong personal support and technical competence and experience to ensure customer expectations will be met or exceeded.

Our line of clinical products is for in vitro diagnostic use. Our clinical test kits are used in hospital laboratories, clinical reference laboratories, universities, and pharmaceutical companies. Our line of research products includes hemostasis kits, substrates, antibodies, and enzymes. We also supply apoptosis detection kits for R&D of anti-cancer drugs and liver disease, ecotoxicology ELISA kits, and liver/kidney biomarkers. These products are marketed to researchers and medical corporations for use in product development, clinical research studies, and in quality control laboratories.

Job Description:

Diapharma seeks a QA/RA Manager.

This is a part time position. Hourly, non-exempt.

Flexible schedule, but must be available to lead internal and regulatory agency audits and adjust hours as necessary during these occasions. Generous salary commensurate with experience.

The QA/RA 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.

  • Serve as Management Representative
  • Promote audit readiness, prepare company for audits by external bodies, including FDA, Health Canada, and customers, and facilitate audits as needed
  • Ensure compliance to FDA and Health Canada regulations
  • Ensure/follow up/implement corrective actions that are raised by deviations, internal audit or regulatory inspection.
  • Manage Document Control, CA/PA, and Training processes and personnel.
  • Manage quality systems, processes and procedures to assure product quality and safety across the business.
  • Engage strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs).
  • Own the development and maintenance of policies and procedures for departmental functions.
  • Influences site compliance to Quality Policy and Quality Management System procedures.
  • Influence participation in compliance to internal and external regulations.
  • Influence quality system metrics such as Corrective and Preventive Action, training metrics, completion and complaint resolution metrics.
  • Manage key quality and regulatory affairs initiatives to drive continuous improvement
  • Spearhead regulatory submissions and regulatory activities, such as 510(k) and de novo submissions
  • Ensure those working within warehouse for shipping and receiving activities comply with procedures.

Qualifications:

  • Bachelor’s degree or higher.
  • Three to five (3-5) years of experience working in the medical device industry, specifically in Quality Assurance and Regulatory Affairs.
  • At least three (3) years of management experience.
  • Demonstrated experience in the medical device industry and knowledge of quality system regulations (e.g. QSR, ISO 13485, MDSAP). This includes experience with Quality System functions like Design Control, DMRs/DHFs, CAPA, Complaints, Risk Management, Document Control, Training, Complaint Handling, and Audits.
  • Experience preparing FDA submissions, license applications, registrations and other product approval documentation and demonstrated knowledge of applicable requirements and practices.
  • Analytical & problem-solving skills/root-cause analysis.
  • Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.
  • Must be willing to take a drug test and submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background.
  • Must be willing to work in West Chester, Ohio.
  • Ability to travel 10% of the time

Diapharma is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against based on their race, gender, sexual orientation, gender identity, religion, national origin, age, disability, veteran status, or other protected classification.

If you meet the above requirements, please email your resume to employment@diapharma.com.