DH Quality Assurance Spclst - Deephealth

Job Description:

Job Summary

The Quality Assurance Specialist is responsible for supporting the Quality Management System throughout the organization in support of product maintenance, development, and growth.  The Quality Assurance Specialist will, with direction, be responsible for document management, QMS training, complaint and CAPA management.

Essential Duties and Responsibilities:

• Own and lead the document management process, including configuration management.
• Work cross-functionally to lead the complaint management process, including investigations, customer interactions, and reporting to management
• Lead the CAPA management process to work cross functionally to identify root causes, and implement remediations
• Lead the QMS training (and retraining) to ensure compliance with US and International requirements.
• Assist in the evaluation and qualification of suppliers.
• Complete Quality System Audits (internal and external audits) to ensure compliance.

 

Please Note: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above.  Other functions may be assigned, and management retains the right to add or change duties at any time.

 

Minimum Qualifications, Education, and Experience

• Bachelor’s degree in relevant field (or equivalent experience, i.e. Associates Degree with 3 years of experience)
• Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
• Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62034 preferred.
• 2 - 4 years working in a regulated industry (FDA and Software as a Medical Device preferred)
• Participation in regulatory audits a plus
• Excellent written and oral communication skills

 

 

Quality Standards:

• Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co-workers, patients, visitors, and vendors.
• Demonstrates initiative, personal awareness, professionalism and integrity, and exercises confidentiality in all areas of performance.
• Follows all local, state and federal laws concerning employment to include but not limited to: I-9, Harassment, EEOC, Civil rights and ADA.
• Follows OSHA regulations, RadNet and site protocols, policies and procedures.
• Follows HIPAA, compliance, privacy, safety and confidentiality standards at all times.
• Practices universal safety precautions.
• Promotes good public relations on the phone and in person.
• Adapts and is willing to learn new tasks, methods, and systems.
• Reports to work regularly as scheduled; consistently punctual with respect to working hours, meal and rest breaks, and maintains satisfactory personal attendance in accordance with RadNet guidelines.
• Consistently adheres to the time management policies and procedures.
• Completes job responsibilities in a quality and timely manner.

 

Working conditions:

Remote setting

 

Physical requirements:

This position often requires sitting for an extended period of time.

 

Accommodations:
Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.

 

 

Pay Range:USD $120,000.00 - USD $135,000.00 /Yr.Shift:MorningsShift Variations:Monday-Friday