QUALITY LEADER

Company Info
Dynamix Group
OH, United States

Phone:
Web Site: http://dynamix-group.com/

Company Profile
col-narrow   

Title:

QUALITY LEADER

Location:

Boston, MA 

Job ID:

67379
col-wide   

Job Description:

Responsibilities
§  Provides leadership and direction to Technicians and Analysts by coaching, supervising, and monitoring direct reports through ongoing performance feedback.
§  Prepares and delivers quarterly performance check ins and final performance reviews
§  Coaches employees on development plans and actively support employee development.
§  Supports the implementation and maintenance of quality systems, including data analysis to identify opportunities for quality system improvement.
§  Maintain independence and oversight for product review and approval.
§  Reviews and approves protocols and final reports; escalate deviations from performance standards to their management.
§  Monitors and manages site CAPA’s Non-Conformances and Customer complaints.
§  Writing and reviewing quality system work instructions.
§  Monitors document control, change control and local supplier activities
§  Maintenance and execution of monthly quality metrics reporting.
§  The Lead, Quality Operations is responsible for self-monitoring of their site’s Quality Management System as well as conducting internal audits at sister facilities to ensure the Quality Management System is meeting regulations and standards.
§  Perform quality system audits and related tasks including pre-planning, execution and report writing.
§  Host/support regulatory, Notified Body and Customer inspections, including back office support, ensuring requests are met timely and with the highest level of professionalism.
§  Responsible for conducting and/or supporting audit finding investigations including but not limited to mitigation, corrective action(s) and preventive action(s) where applicable. Collaborate with department managers to develop and implement sustainable remediation action plans.
§  Leads continuous improvement projects for facility.
 
Requirements
  • A Bachelor's Degree is required.  An Engineering or Technical Degree is a plus.
  • An ASQC Certification is a plus.
  • 5+ years professional Quality experience, preferably including regulatory affairs, legal or governmental compliance, quality systems, internal auditing, applicable scientific, technical or clinical functions and/or healthcare industry experience.
  • Experience in a regulated industry is preferred such as Medical Device, Pharmaceutical, Aerospace, Automotive, Food & Beverage.
  • Experience working in an ISO certified environment required….ISO 13485 is ideal.
  • Management or Leadership experience would be helpful.