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.

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.

Other details

• Pay Type Hourly

Apply Now

• Grand Rapids, MI, USA