Available Position (Company name withheld)

• Autism (including Asperger’s and PDD-NOS)
• Attention Deficit/Hyperactivity Disorder (ADHD) or Attention Deficit Disorder (ADD)
• Learning Disability (e.g., dyslexia, dyscalculia, dysgraphia)
• Intellectual Disability
• Obsessive Compulsive Disorder (OCD)
• Tourette Syndrome

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• Assist all company employees with document numbering, creation, and revision control processes.
• Review document and component change requests to ensure completeness and accurate information.
• Review all production purchase requests to cross-check component part numbers, revision, and vendor against the approved parts database.
• Review incoming inspection records for completeness. Route forms for electronics signatures. Escalate quality issues in cases of documentation discrepancies or non-conforming parts.
• Review production forms and other quality records for completeness and adherence to good documentation practices.
• File quality records as physical or electronic records and retrieve files as requested.
• Follow up on open tasks and issues and ensure update of quality system lists and logs.
• Prepare monthly and ad hoc QMS and project reports.
• Assist in data entry tasks for document and product change requests.
• Assist in computer system validation activities.
• Provide training and guidance to employees on document and change control, quality control procedures, and best practices to promote a culture of quality and continuous improvement.
• Other duties as assigned.

• Excellent attention to detail.
• Ability to read and interpret instructions and communicate deficiencies effectively to other team members
• Strong work ethic and passion to learn and contribute as a member of a high performing team
• Organization skills
• Proficient typing and editing skills
• Ability to handle and prioritize multiple projects simultaneously.

• Between Basic and Intermediate skill level with Microsoft Office programs (Word, Excel, PowerPoint) and SharePoint
• Ability to become proficient in Electronic Document Management Systems (EDMS) and using electronic signatures (Adobe sign)

• College diploma or Bachelor’s degree in Science or a related field
• Nice to have (but not required):
  • Certification in a quality-related or manufacturing discipline

• Nice to have (but not required):
  • 1-2 years experience in a quality-regulated environment (e.g., medical devices/pharmaceutical manufacturing, automotive, aerospace, etc.)
  • Experience in start-ups requiring the ability to work on multiple tasks and take initiative in continuous improvement of the quality system.
  • Experience working with computerized quality management / PLM systems

• Oral communication: Daily
• Email communication: Daily
• Instant messaging: Daily, MS Teams
• Telephone Communication: N/A
• Video communication: Weekly, MS Teams
• Interacting with supervisors: Daily
• Interacting with peers: Hourly
• Interacting with customers: N/A
• Selling or influencing others: N/A
• Training or teaching others: Weekly

• Working in a fast-paced environment to meet time sensitive requests
• Managing changing priorities and requests from multiple teams at the same time
• Producing specific records during audit situations to validate information is accurate

• The quality department is integral to the organization and interacts with all other departments, providing insight into all aspects of the company
• Working in the field of organ transplantation, you are part of a team that makes organs more accessible to those who need them

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Equal Opportunity & Access Statement

Specialisterne USA is an equal opportunity employer committed to building an accessible, neurodiversity-affirming, and inclusive workplace. We value the identities, lived experiences, perspectives, and contributions that each person brings to our team. We welcome applicants from all backgrounds, especially those whose experiences deepen our understanding of disability, neurodiversity, inclusion, and workforce access. Employment decisions are based on qualifications, role requirements, merit, and organizational needs. We are committed to providing reasonable accommodations and ensuring an accessible application process for candidates and employees.