Serves as the support, collaboration, communication, and document review administrative assistant resource in the RA/QA Department. Directly supports the Regulatory Affairs, Quality Assurance, and Quality Engineering functions. The position provides an opportunity to gain hands-on learning experience about the regulated medical device industry while assisting members of the Regulatory and Quality team by providing organizational and informational support. This position requires a critical thinker with an eye for detail and the ability to work in a multifaceted, fast-paced environment. Serves as a flexible resource to handle ad hoc needs of the RA/QA department. Administrative duties and responsibilities can vary widely depending upon company priorities.
Director of RA/QA
Hourly plus company benefits
40 hours per week minimum on site Monday to Friday from 8:00 am to 4:30 pm with occasional overtime.
- Within RA/QA team, serves as direct support for coordination, collaboration, and communication for Quality Assurance, Regulatory Affairs, and Quality Engineering.
- Attends scheduled meetings and prepares a variety of documents (e.g., agendas, minutes, and correspondence) for the purpose of communicating information to the team and other stakeholders.
- Assists in the preparation of regulatory documentation (create bookmarks, hyperlinks, validating, etc.) for electronic submissions to regulatory authorities.
- Maintains multiple Excel databases with information that is created on a daily basis.
- Compiles data and statistics needed for effective departmental operation.
- Provides support to the documentation system and implementation of the Quality Management System (QMS) in compliance with ISO Certification and regulatory requirements.
- Coordinates Document Control administrative activities by reviewing change requests for grammatical errors and completeness, routing documents for signature (both paper and electronically), ensuring relevant approvals have been obtained, and communication and outputs of changes have been completed.
- Utilizes template documents to transfer contractor QMS documents into SAM Medical formats.
- Prepares Certificates of Conformance for approval as requested by customers and distribution partners.
- Reviews production documentation for completeness and accuracy.
- Scans and maintains electronic RA/QA documentation, files hardcopy documents in the relevant location.
- Assists in the development of reports and presentation materials using PowerPoint and other tools.
- Responds to inquiries from a variety of stakeholders for the purpose of providing information and facilitating communication among stakeholders.
- Effectively plans and executes project tasks to support Department goals.
- Participates on cross-functional teams as required to improve QMS processes.
- Coordinates shipments of products for testing and post-market surveillance returns
- Perform other duties as assigned by Director of RA/QA.
- Perform all work in compliance with company policies and within the QMS guidelines.
Required Certifications and Licenses:
- Must be able to sit for extended periods at a desk using a computer.
Qualifications, Skills & Competencies:
- High school diploma, college education highly preferable.
- US citizen or permanent resident
- Minimum of two years of administrative experience, previous work in a regulated industry preferred.
- Must have excellent planning and organizational skills with the ability to manage time effectively in both a team environment and as an individual contributor.
- Technical expertise in working with computers and electronic data management applications.
- Demonstrated proficiency with Microsoft 365 Suite programs (Word, Excel, Outlook, Notes and PowerPoint) and Adobe Acrobat, including form creation and electronic routing for signatures in electronic collaboration environments.
- Able to work collaboratively with RA/QA personnel
- Self-motivated and able to work independently on assigned tasks with minimal supervision.
- Must have excellent verbal and written communication skills.
- Active listening skills and able to communicate in a friendly and courteous manner.
- Completes work assigned in a priority-oriented manner.
- Ability to multi-task while maintaining complex schedules and managing administrative support duties.
- Strong practical nature keeping things simple and well organized.
- Must have a pleasant character, acts professionally, and has good problem-solving skills.
- Quick learner with flexibility to rapidly adapt to change.
- Commitment to continuous improvement and regulatory compliance.
The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities associated with it. SAM Medical management reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
SAM Medical is an equal opportunity employer and does not to discriminate against any employee or job applicant because of race, color, religion, national origin, sex, physical disability, or age.
US military veterans will be given precedence over equally qualified applicants.