Part Time Quality Systems Administrator

Axena Health believes in empowering motivated individuals who demonstrate the ability to set goals, own decision-making and deliver results while working in teams of diverse and high-performing employees, tackling underserved areas of women?s health. If you have a bias for action and want to make an impact in a growing women?s health medical device company supported by world-class investors... we?ll help you advance your skills and career while improving health outcomes and the standard of care for female pelvic floor disorders.

A brief introduction to the role:

The Quality Systems Administrator plays a crucial role in supporting and enhancing our Quality System. Collaborating closely with team members across the department and organization, this position ensures the accurate maintenance and facilitation of quality-related records and training, while driving compliance with quality standards. Your primary focus will be to keep Axena aligned with all compliance policies and procedures, ensuring that our Quality Management Systems (QMS) remain current and effective.

We are looking for someone to work a consistent schedule week over week between 20 ? 24 hours per week. This could be five, 4.5 hour days or three 8 our days or something in between.

Responsibilities include:

? Maintain and oversee the quality and compliance training program, ensuring all employees are up-to-date on relevant processes and procedures.

? Collaborate with department managers to develop, implement, and regularly update training plans that align with job descriptions, clearly identifying and documenting training requirements.

? Monitor and report on key metrics related to the effectiveness of training programs and overall quality system performance, providing actionable insights.

? Provide training and ongoing support in the use of the Quality Management System (QMS) to ensure proper understanding and compliance.

? Manage and coordinate change control activities, particularly for the control and approval of promotional materials and quality system documentation.

? Coordinate quality system processes, such as non-conforming materials, complaints, and CAPA (Corrective and Preventive Action) processes, to ensure records are audit-ready and compliant.

? Support internal and external audits, including preparing documentation and assisting with audit readiness and responses.

? Maintain and regularly update quality system procedures and work instructions, ensuring they are compliant with applicable regulations and standards.

? Ensure continuous improvement of the quality system through regular reviews, updates, and corrective actions as needed.

? Perform additional duties as assigned to support the Quality Management System's overall goals

Qualifications needed:

?High School Diploma required; associate's degree or higher preferred.

?Minimum 3 years of practical experience in quality system administration within medical device, pharmaceutical, healthcare, or consumer product-related industries.

?Knowledge of FDA 21 CFR 820 regulations is strongly preferred.

?Proficiency in Microsoft Office, especially advanced Excel (VLOOKUP, SUMIF, PivotTables) to analyze and manage data efficiently.

?Experience with Salesforce or similar electronic QMS systems is preferred.

?Strong oral and written communication abilities with the capacity to influence and engage diverse audiences. Skilled in handling sensitive situations professionally at all levels.

?Demonstrates persistence and creativity in overcoming obstacles and driving results. Focuses on practical solutions that lead to successful outcomes.

?Takes ownership of high-quality work and is committed to delivering exceptional service. Ensures all agreements and commitments are met in a timely manner.

?Operates effectively in a fast-paced environment with the ability to prioritize, multi-task, and escalate issues when necessary.

?Thrives under pressure and works with a sense of urgency.

?This role will be remote, from your home office which requires a quiet and private workspace as well as reliable and strong internet. Occasional business travel is required with this role although it will be minimal.

Compensation & Benefits: An hourly rate of $35-$40/hour based on experience level in previous quality roles & location. As an employee working under 30 hours per week, Axena does not provide a benefits package. This role is eligible for paid time off.

Additional Information:

Axena Health is dedicated to improving the lives of women with pelvic floor disorders. Axena Health?s flagship product, the Leva?Pelvic Health System, offers a novel, effective, first-line treatment for urinary incontinence (UI) and chronic fecal incontinence (FI), underreported conditions affecting over 78 million and 12 million women in the U.S. alone. Axena Health's technology enables non-invasive, drug-free treatment via precise visualization of movement in real time during pelvic floor muscle training, while monitoring usage and progress.

Axena Health is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Axena Health is an E-Verify Employer in the United States. Axena Health will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law

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