Quality Assurance - Document Control Coordinator

POSITION TITLE: Document Control Coordinator DEPARTMENT: Quality

Main Purpose Of Job

Maintains the Viant Laconia Document Control System ensuring only the latest revision documents are in use and distributes new or revised documents.

MAIN JOB RESPONSIBILITIES: POSITION REQUIREMENTS: Knowledge/Education: Job Experience: Skills/Competencies:

• Ensure Viant Laconia Document Control System meets or exceeds the requirements of ISO 13485, FDA, QSRs, and customer requirements.
• Ensure all documents pertaining to the Viant Laconia Quality System are controlled and only the latest revisions are in use.
• Prepare and control label Masters.
• Issue RMA numbers to customers when requested.
• Maintain certification files.
• Maintain organized and accessible Quality records.
• Maintain obsolete document files.
• Issue new and revised documents and retrieve outdated copies.
• Provide support within the organization as experience and time allow.
• High School Diploma or equivalent
• Experienced in Microsoft office suites (excel, word, power point, outlook)
• Solid experience with quality systems documents
• Strong organizational skills with proven ability to complete multiple tasks simultaneously
• Strong understanding of FDA CFR 820, ISO 13485
• Minimum of two (2) year’s-experience in an office environment or equivalent college training.
• Ability to communicate and work with those inside and outside the department, handle multiple assignments and prioritize accordingly.
• Ability to follow appropriate department policies, procedures and practices.
• Positive teamwork attitude.
• Good problem-solving skills.
• Good writing and verbal skills.
• Understanding of Lean Manufacturing philosophies
  
  

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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