Document Control Coordinator

Job Description:

GENERAL NATURE AND SCOPE

The Document Control Coordinator will manage the Quality System Document Control process in compliance with applicable regulatory requirements, which includes overseeing document and record control operations, policies, and procedures. This position is on-site in Romulus, MI.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Other duties may be assigned, in addition to those identified below.

• Performs all duties in compliance with FDA, ISO, EPA, OSHA, and other current regulatory requirements.

• Maintain original and authorized copies of quality system documents, or other components of the quality system. Maintain all records in an accurate and orderly condition and readily available for review or audit by authorized personnel. These records include: Device Master Records, product and component specifications, Electronic Change Orders (ECOs) and any other files or records which QA management may designate.

• Maintains Device Master Records by processing Engineering Change Orders as submitted to Document Control for implementation into the quality system. This includes completion of all required supporting actions/documentation prior to final issue.

• Assist in the facilitation of any audits performed by corporate auditors or external inspectors/assessors. May assist with internal auditing of the quality system.

• Perform various other tasks and administrative assistance as may be required by QA management in support of the quality assurance system.

• Assist with other quality system processes such as Corrective & Preventive Action (CAPA), Material Review Board (MRB), Complaint Handling, Post Market Surveillance, etc.

• May be required to provide similar assistance to other Document Control departments within the corporation as directed by QA management.

Job Requirements:

EDUCATION and/or EXPERIENCE

• Associate's degree or equivalent experience in Medical Device Quality Systems and Document Control

• A minimum of 2 years' experience in quality assurance or quality systems required; medical device or dental industry experience is preferred

• Proficiency in the use of personal computers and computer database software, including Microsoft Office applications (Excel, Word and PowerPoint) required. Familiarity with electronic document control software preferred.

• Ability to organize and maintain accurate, legible, quality system records and associated and supporting documentation.

PREFERRED QUALIFICATIONS

• Experience with Master Control and/or Oracle is a plus

• Working knowledge of the FDA Drug Regulations, FDA medical device Quality Systems Regulations and international quality system standards is preferred

• Must be able to identify and recommend effective solutions to problems, utilizing technical problem-solving tools, and working individually and with others within and outside his/her function.

• Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations.

• Must show self-initiative but be comfortable in the role of a team player. Must be able to manage multiple projects and report progress against goals in an objective manner.

• Proficiency in project leadership and management.

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.

COMPETENCIES

• Analytical Decision-Making

• Communication

• Learning & Development

• Planning & Organizing

• Professionalism & Integrity

• Risk-Taking/Creative Thinking

• Teamwork & Relationship-Building

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Operating Company:

Kerr

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