Quality Documentation Specialist

Summary:

The Quality Documentation Specialist support the preparation, completion, and revision of nonconformance records using controlled Microsoft Word templates, previously approved examples, and manufacturing/quality data from authorized internal systems. This is a high-volume documentation execution role.

Hours: 8am to 5pm (M-F)

Essential Duties & Responsibilities

• Prepare and update nonconformance records using standardized Word templates and approved examples; adapt each record to its specific event rather than copying unverified content.
• Ensure an accurately documented problem descriptions, identified containment, scope of impact, part and lot numbers, quantities, and other required fields using verified source information and provided guidance.
• Navigate Oracle and other authorized systems to retrieve manufacturing orders, inventory, traceability, and quality information; cross-check entries for consistency.
• Identify missing, conflicting, or unclear information; proactively ask Quality, Manufacturing, Engineering, Production or other relevant personnel for clarification in person, by email, or through Teams.
• Incorporate reviewer comments quickly and accurately, manage revision cycles, and resubmit documents for review.
• Track assigned, in-progress, awaiting-input, and completed records; meet agreed productivity and quality expectations.
• Follow applicable documentation procedures, data integrity practices, and access controls; escalate issues rather than making unsupported assumptions.

Knowledge, Skills & Qualifications:

• Strong Microsoft Word skills, including templates, tables, formatting, editing, and revision management; working knowledge of Excel, Outlook, and Teams.
• Ability to navigate ERP and other electronic systems and accurately transfer and reconcile information across sources.
• Excellent attention to detail, organizational skills, logical reasoning, and written communication.
• Comfortable performing repetitive, high-volume work with sustained accuracy and responsiveness to feedback.
• Proactive, approachable, and willing to walk to the appropriate department to resolve questions when necessary.
• Ability to follow defined instructions and work independently after training.

• General understanding of a plastic component structure and role of product specifications
• Ability to become knowledgeable in departmental procedures, GMP's, Specifications/Guidelines, product lines/processes and commodities
• Familiarity with the importance of clear documentation and guidelines governing medical devices.
• Strong verbal and written communication skills

• Experience in quality documentation, document control, manufacturing administration, or quality assurance support.

Education and Experience:

• Associate degree or equivalent combination of education and relevant work experience required.
• Degree field is not required; candidates with backgrounds in quality, manufacturing, life sciences, business, technical disciplines, or related fields are encouraged to apply.
• 1+ years of experience in a quality, manufacturing, regulatory, compliance, documentation, or related operational environment.
• Experience reviewing, documenting, and processing quality or regulatory records preferred.
• Experience following established procedures, workflows, decision trees, or quality system requirements.
• Experience working in a regulated environment is preferred but not required.

Physical Requirements and Work Environment:

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets.
• While performing the duties of this job, the employee may be required to sit or stand for long periods of time.
• Must be able to occasionally move and lift objects of up to 25 pounds.