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AirStrip

Mobile healthcare technology for caregivers to collaborate and care for their patients.

Manager Quality Assurance and Regulatory Affairs
San Antonio, TX, US
Job Description / Skills Required

AirStrip makes transformational and lasting improvements in worldwide healthcare delivery by creating innovative technology for caregivers to collaborate and care for their patients. AirStrip provides a complete, vendor and data source-agnostic, enterprise-wide mobile interoperability platform that advances care collaboration and serves as a catalyst for health system innovation. With deep clinical expertise and strong roots in mobile
technology and data integration, AirStrip is empowering leading
health systems globally as the industry evolves at a rapid pace. Based in San
Antonio, Texas, AirStrip allows health systems to unlock the full potential of
their existing technology investments with a mobile interoperability platform that provides access to critical patient data and intelligent insights
across the care continuum.

AirStrip is seeking a Manager Quality Assurance and Regulatory Affairs.

This role ensures AirStrip medical devices comply with the US and International regulations/ requirements and standards and performs regulatory submissions for AirStrip products.

Essential Duties and Responsibilities:
Manages, documents and maintains regulatory submission documentation (E.g. technical files, 510(k) documentation, and international regulatory submissions (e.g. Canada, Australia, EU, Middle east))
Reviews and provides regulatory guidance for internal and external documentation, collateral and other labeling materials
Participates in the Design Control processes as the independent reviewer to ensure compliance with national and international regulations and standards, and internal operating procedures
Collaborates with cross functional partners and process owners to develop and report Quality Metrics necessary to identify adverse trends and ensure continual improvement of the Quality Management System
Collaborates with cross-functional partners and process owners to improve processes based on results of quality indicators such as audits, CAPA, complaints, and non-conformances.
Tracks the timely implementation and effectiveness of corrective / preventative actions.
Manages suppliers and conducts supplier site evaluations / supplier qualification activities
Manages corporate patient health information, quality and other compliance training activities
Develops, maintains, and tracks adherence to the internal audit plan; conducts independent internal audits.
Work collaboratively with other departments on other duties as assigned.

Minimum Qualifications:
Minimum of 5 years experience with the above-specified responsibilities in a regulated medical device environment.
Strong computer skills and experience with Microsoft Office / electronic record-keeping
Demonstrated high attention to detail
Demonstrated effective interpersonal skills
Demonstrated ability to independently execute actions
Effective oral and written communications skills and ability to communicate effectively.

Travel Requirement:
10% travel with some overnight stays as necessary

Education/Certification Requirements:
A Bachelor’s Degree in a technical discipline or equivalent combination of education and experience in medical device quality systems and/or biomedical engineering. Certified Quality Auditor Certification preferred.

Physical Demands:
The employee may on occasion lift and/or move 10-25 pounds. The employee is frequently required to sit for prolonged periods of time. While performing the duties of this job, the employee will be required to hear/speak to customers via phone related to our products. This position requires the ability to see and enter data within a computer system on a
regular basis. The employee may also be required to drive to a location to meet the standards of this position.

Overnight on call and weekend assignments may be performed remotely.

Work Environment:
Day to day work includes desk and personal computer work and interaction with Corporate, Business Unit Area and facility managers. The work environment is characteristic of an office and health care facility with air temperature control and moderate noise levels.

Benefits:
In return for your hardwork and dedication , we offer a competitive salary and an extensive benefits package including medical, dental, vision, paid time off and a retirement plan.
Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.

To Apply:
To respond to this opportunity, please send a current resume