Documentation Control Clerk

Job Description:

Confluent Medical Technologies is a financially healthy and rapidly growing medical device company dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

We are looking for a Documentation Control Clerk to join our team in Costa Rica. If you enjoy working in a fast-paced environment and making an impact on our life-saving work, this may be a good fit for you! You will be responsible for executing documentation control tasks and supporting quality system audit activities.

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.

• Execute, document, control operative tasks, including scanning of documents, distribution of new release document, enter training records in Compliant Pro, audits and reviews quality records that are received by doc control.

• Coordinates documentation flow in and out of the site to other sites and external document supplier.

• Collaborate with Quality system audits, including training audits, GMPs and GDPs, workstation practices, binder documentation audits, etc.

• Other duties in the Quality Assurances area.

EDUCATION and/or EXPERIENCE:

• High school diploma required; currently pursuing a college degree preferred

• Intermediate English proficiency (B1 level) is a requirement

• Minimum of 2 years of experience in the medical device industry

• Proficiency in computer tools, including email, databases for routine activities, word processing, spreadsheets, and graphic software

OTHER SKILLS AND ABILITIES:

• Ability to read and understand technical documentation related to specific discipline

• Must successfully complete internal training courses in manufacturing techniques

• Willingness and ability to learn regulatory requirements (GMP)

• Ability to read and understand simple instructions, brief correspondence, and memos, as well as to write basic communications

• Ability to perform basic mathematical operations (addition, subtraction, multiplication, and division) across all units of measure, using whole numbers, fractions, and decimals

• Ability to calculate rates, ratios, and percentages, and to prepare and interpret bar