SUMMARYThe Quality Systems Specialist II implements Dynatronics’ One-Company Quality Management System for assigned business/site. S/he is responsible for maintaining compliance with applicable regulatory requirements, in addition to ensuring all products adhere to the highest levels of quality standards.
ESSENTIAL FUNCTIONS & RESPONSIBLITIES- Work with Operations personnel to document current manufacturing and assembly procedures
- Administer/support medical device quality system elements per Table 1
- Maintain regulatory records per Table 1 in accordance with regulatory standards as documented in company SOPs
- Develop and monitor quality system metrics per Table 1, as an input for continuous improvement and periodic corporate Quality Management Review Meetings
- Support internal audits, and external Quality Systems audits conducted by regulatory authorities and customers
- Perform additional, related duties as needed
Table 1
QMS Responsibilities
System
Role
Coordinate With
QS Metrics
Document Control and Approval
Administer
Yes
CAPA
Administer
Yes
Customer Complaints and Complaint Files
Administer
Customer Care
Yes
Employee Training
Administer
Human Resources
Yes
Design Control, DMRs, and DHFs
Support
Engineering, Customer Solutions
Supplier Quality
Support
Supply Chain
Yes
Production/Process Controls and DHRs
Support
Operations
Yes
Calibration
Support
Operations, Engineering
Product Acceptance and Release
Support
Operations, QC
Identification and Traceability
Support
Operations
Nonconforming Product
Support
Operations, QC
Yes
Labeling and Packaging
Support
Sales, Marketing, Operations
Regulatory Records shown in blue
Qualifications COMPETENCIES- Thorough knowledge of FDA QSR required; knowledge of ISO 13485 required
- Excellent attention to detail required
- Excellent written and oral communication skills – English required, Spanish preferred
- Good cross-functional teamwork skills
- Good time management and organizational skills
- Exceptional customer service and interpersonal skills, able to build strong relationships and maintain rapport cross-functionally and with external customers
- Ability to work independently with minimal supervision and also work on a team
- Alignment with DYNA mission, vision, and core values
EXPERIENCE & EDUCATION
- Associate’s college degree required; Bachelor’s college degree preferred
- Medical device industry experience required (3 years minimum)
- Documentation and change control experience preferred