Quality System Specialist Ll - MN

The 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.

• 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

• 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