Quality Documentation Coordinator

RXinsider LTD.; Dublin, Northern (OH, KY); Hybrid; USD 38,000 - 52,000; Full time

Job summary

ICU Medical is seeking an administrative specialist to support the release of finished goods. You will manage QA holds, review production documentation, and release conforming products through Oracle, while maintaining DHR and sterilization records.

Knowledge of ISO13485 and FDA requirements is a plus. This role requires 1-2 years of clerical experience, strong communication skills, and the ability to work in a fast-paced environment.

Qualifications

• 1-2 years administrative or clerical experience preferred.
• Microsoft Office experience preferred, but not required.
• Familiarity with regulatory standards such as ISO 13485 and FDA requirements is a plus.

Responsibilities

• Release finished goods through Oracle after review and approval of documents.
• Maintain QA hold process for nonconforming products.
• Perform final quality review of production and sterilization documentation prior to release.
• Generate Sterility and Certificate of Conformance letters.
• Maintain DHR and outsourced sterilization documentation and files.
• Ensure compliance with applicable laws, regulations, standards and company procedures.

Skills

Administrative experience

Microsoft Office

Data entry

Communication skills

Teamwork

Regulatory knowledge

Education

High School diploma

Tools

Oracle

Job description

Job Description

Position Summary

This role is responsible for releasing finished goods through Oracle following review and approval of appropriate documents ensuring product quality and regulatory compliance. Manage nonconforming products through QA hold processes, conducting final reviews of production and sterilization records, releasing finished goods through Oracle, maintaining DHR and outsourced sterilization documentation, and generating required quality certificates. The position also supports compliance with applicable laws, regulations, standards, and company procedures. Additional responsibilities are performed as assigned by the supervisor.

Essential Duties & Responsibilities

• Maintain control of non-conforming products through QA hold process.
• Perform final quality review for all production and sterilization documentation prior to product release.
• Release all conforming finished product through Oracle.
• Perform filing of DHR (device history record).
• Generate Sterility and Certificate of Conformance letters.
• Review documentation and release of outsourced sterile product and maintain files.
• Maintain control of non-conforming products through Oracle QA hold.
• This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
• Other duties as assigned by supervisor.

Knowledge, Skills & Qualifications

• High School Diploma or equivalent.
• 1-2 years administrative or clerical experience preferred.
• Microsoft Office experience strongly preferred, but not required
• Previous Oracle experience preferred, but not required
• Previous medical device knowledge preferred, but not required
• Familiarity with regulatory standards such as, ISO 13485, and FDA requirements.
• Excellent communication skills (written and oral), and interpersonal skills.
• Ability to work closely in a team environment
• Ability to multitask
• Basic math skills.
• Ability to work effectively in a fast-paced, dynamic environment.

Education And Experience

• High School Diploma is required

Travel Requirements

• Typically requires travel less than 5% of the time.

Physical Requirements And Work Environment

• Must be able to perform essential job functions in an office environment.
• Long periods of sitting to enter/ analyze data is expected
• Must have adequate manual dexterity to operate standard office equipment
• Must be able to occasionally lift objects up to 25 lbs.

About Us

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. Our Focus Allows Us To Bring You

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement

ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [e-mail]. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

ICU Medical CCPA Notice to Job Applicants