Quality Specialist

2 weeks ago

San Ramon, United States Atlas Lift Tech Full time

_**This is not a lab position**_

**About the Company**

Atlas Lift Tech, Inc. is a mobility solutions provider. Our solution integrates evidence-based best practices in high-risk Hospital Acquired Pressure Injury (HAPI), patient falls and Safe Patient Handling and Mobility (SPHM) activities. We work alongside each facility to create a customized solution that meets the needs of clinician and patient populations. Our Mobility Technicians are able to capture leading, lagging and real-time indicators through the Atlas Mobility Cloud Software as well as our hardware technology in development to guide and supply evidence to hospital leadership for decisions that impact complications due to immobility.

In order to further our impact in the healthcare industry, Atlas Lift Tech, Inc. has also begun our journey in the medical device space. Our product will help the caregivers with the monitoring and tracking of industry-recommended patient turns and positions to assist with preventing hospital acquired pressure injuries.

We are already changing the lives of healthcare professionals and their patients, but we feel we can do so much more. To do this, we need professionals like you who can help advance our systems to the next level. We will stretch your skills and elevate your ability to grow personally and professionally. Along the way, you will learn new skills and get to play with some kick ass toys. Your work will directly contribute to saving and improving people’s lives.

**Overview**

We are seeking a detail-oriented and experienced Quality Specialist to join our team. The Quality Specialist will be expected to use training, experience, and good judgement to perform tasks assigned in the Quality Department.

**Responsibilities**
- Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items.
- Assist Complaint program at Atlas Lift Tech including tracking, trending, and updating associated metrics.
- Completes Regulatory Risk Assessments related to Complaints.
- Maintain the supplier activities and implementation of them into the Quality Management System. Review trends and data on suppliers and discuss with the Quality manager any issues that need to be addressed.
- Assist with Root Cause Analysis
- Responsible for document control
- Responsible for the revision, distribution and maintenance of controlled documents including Standard Operating Procedures, Work Instructions, Forms, specifications, and other miscellaneous documents.
- Assist in preparation, submission, and maintenance of regulatory filing documents with the appropriate local, state, and federal agencies.
- Responsible for maintaining controlled document libraries.
- Coordinate requests for Change Orders, including preparing supporting documentation, communications, sample part review and scheduling for projects in engineering and quality.
- Conducts process walks of procedures with other departments.
- Contributes to team effort by accomplishing related tasks as needed. Will be required to perform other duties as required, directed, or assigned.

**Education and Experience**
- Thorough knowledge and minimum 3 years’ experience working in a regulated environment such as medical devices and experience with Quality Management Systems and Medical Device Regulations: CFR 820, ISO 13485.
- Ability to prioritize and shift priorities quickly as needed.
- Team-oriented with commitment to the success of the team and organizational goals to track.
- Certification in Quality field preferred.
- Experience working with manufacturing-based technology processes and principles preferred.
- Must have good verbal and written communication skills.
- Ability to multi-task
- Atlas Lift Tech, Inc. is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law._

Pay: $90,000.00 - $110,000.00 per year

**Benefits**:

- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance

Experience level:

- 3 years

Schedule:

- Day shift
- Monday to Friday

Work setting:

- In-person
- Office

Application Question(s):

- Do you have experience in Medical Device Regulations (CFR 820, ISO 13485)?

**Education**:

- Bachelor's (preferred)

Ability to Commute:

- San Ramon, CA 94583 (required)

Ability to Relocate:

- San Ramon, CA 94583: Relocate before starting work (required)

Work Location: In person

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