Viant Medical Grand Rapids , MI 49504
Posted 4 days ago
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:
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.
Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
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Viant Medical