SUMMARY:

The QMS specialist is responsible for support for LifeSync’s QMS processes. This includes supporting and monitoring effectiveness of non-conformances, deviations, audits findings, and CAPAs. 

The position works closely with Engineering, Manufacturing, and Quality. This position will support the organization obtain all necessary certifications, ensure our products are built consistent with industry standards/regulations, as well as our quality management system (QMS). This is a role that requires broad knowledge in QMS requirements.

DUTIES AND RESPONSIBILITIES:

• Review, update or write standard operating procedures as needed.
• Coordinate, monitor and support non-conformance investigations. 
• Coordinate, monitor and support CAPA investigations. Review and approve CAPAs as needed.
• Coordinate, monitor and support deviation processes. 
• Assists and/or perform training sessions for new hires and current employees. 
• Support internal/external audits. Monitor and assist with audit findings.
• Perform other related duties, as assigned. 

REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• Demonstrated process development and problem-solving skills. 
• Ability to multi-task in an environment where responsibilities tend to encompass more than the job title would indicate. 
• Able to develop and maintain mutually respectful, cooperative working relationships with co-workers, customers and suppliers while promoting a positive company image. 
• Experienced in Microsoft Office, ERP system experience, Microsoft Project.

SUPERVISORY RESPONSIBILITIES: Not Required

EDUCATION AND/OR EXPERIENCE:

• Bachelor’s degree required.
• 3 years of Medical Device Functional Experience (Quality, Clinical, Engineering, Regulatory or equivalent).

PHYSICAL DEMAND: 

The position is a sedentary job. The person must be comfortable sitting at a desk for long periods of time. 

WORK ENVIRONMENT:

The work environment is a typical office environment. 

TRAVEL REQUIREMENT: Not Required

LifeSync provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

The Age Discrimination in Employment Act (ADEA) forbids age discrimination against people who are age 40 or older. It does not protect workers under the age of 40, although some states have laws that protect younger workers from age discrimination. It is not illegal for an employer or other covered entity to favor an older worker over a younger one, even if both workers are age 40 or older.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.