Document Control Specialist 1

Description :

IMPORTANT : Suppliers should not submit workers whose physical residence is within the following states due to Intuitive tax and operating entity structure :

Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.

Please interpret this as Intuitive policy to which all suppliers are required to comply.

Primary Function of Position

Onsite

Interview : 2 rounds, phone screening / onsite

Organize and maintain controlled documentation, including SOPs, technical drawings, specifications, and records

Essential Job Duties

Hard Skills

Quality System Regulations and ISO 13485 requirements.

o Good Documentation Practice (GDP)

ISO 13485 clause :

4 Quality Management System|4.2 Documentation Requirements|4.2.5 Control of Records

Change control and evaluate impact on manufacturing, duplicated production lines, and equipment shared with other BUs

MS Office applications (word and excel) and Windows operating system.

o Able to redline (track changes) in MS word

Excellent computer skills

Proficiency in using databases for document control and change management systems : Agile; SAP; Polarion; Neptune

Experience in automated change control system (ACCS) or document control system (i.e. Agile preferably)

Technical writing

Preferable experience in medical device or other regulated industry

Soft skills :

Cross-functional teamwork

Well-developed written and verbal communication skills

Ability to handle multiple projects and priorities in a fast-paced environment.

Strong attention to detail

Ability to organize and track multiple items of a project simultaneously.

Efficient

Prepare ECOs and associated documentation for review and release in Agile (ACCS)

Ensure all documents comply with organizational standards and regulatory requirements.

Develop and enforce document control procedures and best practices across teams.

Regularly audit documentation to ensure accuracy and completeness

Required Skills and Experience

Strong understanding of change management methodologies and best practices

1-3 year experience in Document, Data, and Record Control Management function

Must have excellent computer skills and be proficient in relevant software tools for document control and change management systems - Agile; SAP; Polarion; Neptune

Ability to handle multiple projects and priorities in a fast-paced environment.

Strong attention to detail and ability to track various components of a project simultaneously.

Required Education and Training

High school diploma or equivalent required

Associates s or bachelor's degree in business administration, quality assurance, or a technical field preferred

1-3 yrs experience with automated change control systems (ACCS); preferably Agile

Working Conditions

Position requires extensive reading, writing and computer-based work.

Qualified candidates must be legally authorized to be employed in the United States. Position does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position.

Preferred Skills and Experience

Familiarity with regulated Quality Systems, especially medical device regulations, a plus

Enable Skills-Based Hiring

Job Posting Type

Additional Details

• Pre-identified worker (First Name, Last Name) & Supplier Name : (No Value)
• Job Posting Type : Agency Recruited Worker Required
• Worker Legal Name (For Manager Sourced Only) : (No Value)