Job Description

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

No

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