Document Control and Quality Specialist

Delphinus Medical Technologies, Inc . is an innovation leader in advanced ultrasound development and the first company to design and manufacture a 3D whole breast ultrasound system that utilizes a dynamic new technique to image the breast with the use of sound and water. Delphinus is committed to creating improved breast imaging methods, while establishing a better patient experience for all women, regardless of age, without the concern of radiation or compression.

Delphinus offers a creative and friendly work environment. Our goal is to ensure team members can bring their best every day, in a comfortable, inventive, and collaborative space. We offer competitive salaries and benefits packages, and the opportunity to grow with the company. If you are looking for the opportunity to join a dynamic team dedicated to developing life-saving technologies, you may be a fit for us!

We are currently seeking an experienced Document Control / Quality Specialist who shares our passion, enthusiasm, and dedication to transforming lives.

Position Summary :

The Quality Assurance Associate will be responsible for supporting the Quality and Regulatory Department through quality system documentation activities.

Primary Responsibilities :

Document Control :

• Oversee centralized library of quality system data and records, ensuring secure processes and limited access
• Implement and maintain document control procedures
• Administer change requests and orders in the electronic lifecycle management system (Arena) in a timely manner.
• Examine documents, drawings, change orders, SOPs and specifications to verify completeness and conformance to company formatting standards.
• Format and edit documents as well as coordinate the review and approval of documents with the appropriate departments.
• Confer with change / document originators liaison personnel to resolve discrepancies and compile required document changes.
• Review records for good documentation practices (GDP), (e.g. – manufacturing and receiving paperwork, quality records)
• Organize and maintain quality system records (electronic and hard copy).
• Train and assist employees in the use of document control systems and procedures

Follow up with other departments on the status of action items related to quality processes.

Enter and / or update quality system information in electronic database based upon team review outcome. (e.g. – complaints, nonconformances).

Assist with regulatory submissions, through printing, labeling, organizing electronic information.

Assist Quality team with various meetings and audit support, including scheduling and scribing.

Education / Certifications :

College undergraduate; preferred.

Work Experience :

3-5 years prior work experience

Computer Skills :

Microsoft Office proficiency

Ability to quickly pick up various database tools (E.g. - PLM / Arena, CRM / SalesForce)

Knowledge, Skills and other Abilities :

Physical Demands :

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

While performing the duties of this job, the employee is regularly required to sit, use hands, and talk or hear. The employee is frequently required to stand, walk and reach with hands and arms. The employee is occasionally required to climb or balance, and stoop, kneel, crouch or crawl.

Work Environment :

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles, and risk of electrical shock.

The noise level in the work environment is usually mild to moderate.

Travel : None.