Quality Compliance Specialist

QUALITY COMPLIANCE SPECIALIST

SUMMARY:

The Quality Compliance Specialist is responsible for the facilitation of all internal, customer, supplier and regulatory audits; oversees CAPA administration, standards coordination leadership, quality; facilitates electronic training system, regulatory training; and provides support for the Quality Managment Review.

MAIN RESPONSIBILITIES:

• Administers the Viant Medical Internal Audit Program
• Schedules, performs, and tracks internal audits
• Facilitates audit non-conformance closures and training
• Leads Customer Audits of Viant Medical
• Develops audit schedules with customers
• Provides Viant Medical subject experts to address audit items
• Coordinates post-audit finding responses to customers
• Provides direct support for FDA, Notified Body, Japanese Govt., and other audits
• Administers CAPA system keeping Senior Leadership informed of issues and progress on resolution
• Interacts with teams on proposing and guiding appropriate CAPA responses and resolutions
• Facilitates CAPA review board meetings, and manages meeting minutes
• Reviews CAPA and provides constructive feedback to CAPA owner in regard to technical documentation
• Monitors new regulatory standards implementation and revisions to current standards, i.e., ISO Standards, FDA Requirements, ASTM
• Advises Senior Management on standards
• Conducts necessary training on standards
• Organizes, plans and performs new employee training on Viant Medical Quality System
• Plans annual schedule of Quality and Regulatory training for employees
• Administers and directs the training programs through Master Control and supporting area trainers
• Works with Quality Director to help organize, prepare and present quarterly Quality Management Reviews
• Coordinates competency training and exams in the electronic Master Control-based document control and training system
• Facilitates necessary role and job code configuration to meet facility and compliance needs

REQUIREMENTS

Knowledge/Education:

• BS/BA in Sciences or Technical Discipline preferred

Job Experience:

• 3-5 years of experience in the Quality or Regulatory field preferred
• Knowledge of FDA QSR, IO 13485 and ISO 14971 Risk Assessment
• Experience in medical device or related regulated industry
• Experience with Electronic Quality Control systems
• Experience with root cause analysis techniques, six sigma, 5P, Ishikawa diagrams desirable

Skills/Competencies:

• Working knowledge of internal and external auditing functions
• Working knowledge of CAPA programs and documentation requirements
• Working knowledge of quality and reliability software
• Excellent communication and technical writing skills
• Ability to interface with customers on technical issues
• Ability to work both independently and in a team-based environment
• Excellent Problem-solving skills
• Knowledge of Microsoft Office Suite (Word, Excel, PowerPoint)

Physical Requirements:

• Work in an office environment with varying amounts of walking, sitting, standing, twisting, and turning
• Periodically lift or carry up to 25 lbs.