Document Control Coordinator

Collaboration drives Nordson’s success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving back in the communities around the world where we live and work.

ESSENTIAL DUTIES & RESPONSIBILITIES:

Follow and work in accordance with Good Manufacturing Practices and Procedures as defined by Nordson Medical’s policies and procedures, ensuring that FDA and Quality Standards are met.

· Maintain, update and archive primary and support documents in the company’s document control system. Coordinate preparation, approval, and implementation.

· Review and process Change Orders (CO).

· Write and/or edit procedures, work instructions, or policies.

· Translate or coordinate the resources to translate documents as required.

· Ensure that documents provided to the manufacturing team are controlled and current.

· Review materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies, and ensure documentation is in English and Spanish.

· Distribute training to individuals and groups as required by training matrices.

· Create and manage training documentation files and follow up on overdue training.

· Assist in identifying training needs and work with all departments to provide effective training, as required.

· Administer Quality training for the site, including new hire training, periodic refresher training, and Quality Corners, as appropriate.

· Generate monthly metrics for incorporation into the Quality Monthly Report and to be posted as part of company metrics. Present data in update meetings.

· Provide additional data to management as required for Management Review and continuous improvement or failure investigation.

· Host or participate in internal or external quality audits; retrieve all requested controlled documents and manage any follow-up activities.

· Manage customer complaints, including communication with the customer, documenting all phases of the process, and tracking the complaint to completion.

· Lead the site’s CAPA Review Board, including coordinating with CAPA owners, monitoring progress, and reporting results to management.

· Respond to internal and external controlled document requests; ensure accuracy of transmitted documents.

· Communicate effectively with all functions at the site, including with the Quality team.

· Exercise independent judgment in selecting and interpreting information and resolving difficulties.

· Maintain competency in all quality processes and procedures according to the training matrix.

· Maintain order and cleanliness of document control area and documentation files.

· Maintain a safe and healthy work environment by aligning with company policies and procedures.

· Participate in continuous improvement at the site.

· Attend regular meetings to update data, guidelines and objectives and provide the knowledge acquired to improve the situation of quality department.

· Act as a consultant for areas related to his/her expertise.

· Other duties or projects as assigned.

MINIMUM QUALIFICATIONS:

Required Education:

· Incomplete Bachelor´s degree or high school completed.

· One year in a similar position in Medical Devices Industry.

· Bilingual English Spanish 80%

Knowledge, Skills & Abilities (KSA’s):

SKILLS AND ABILITIES:

· Team player with flexible attitude and ability to prioritize workload and handle multiple tasks/deadlines.

· Be motivating, proactive and have ability to promote / create a positive and productive environment.

· Ability to develop an understanding and practice of Nordson values.

· Values cultural diversity and other differences; fosters an environment where people who are culturally diverse can work together cooperatively and effectively in achieving organizational goals.

· Highly organized, self-directed, self-motivated, pays attention to detail.

· Ability to adhere to all processes and procedures.

· Fluent in both English and Spanish with ability to accurately review documents in both languages.

· Basic understanding of how to read and interpret drawings, BOMs, charts, graphs and tables of information.

· Preferred:

§ Familiar with a Quality Management System such as ISO 13485 or other regulated environment.

§ Knowledge of good manufacturing practices and good documentation practices.

§ Experience with creating and writing procedures and work instructions.

§ Experience with international standards such as ISO 13485, ISO 9001, ISO 14971, ISO 11137, ISO 14644, FDA and European Quality Systems Requirements QSR, MDD. Experience with DFMEA and PFMEA.

COMPUTER SKILLS:

· Good working knowledge in navigation and use of the Windows operating system in a networked environment.

· Strong understanding on the use of some Microsoft Office Tools such as: Outlook, Word, Excel, Power Point.

· Experience with working within an ERP software system.

· Aptitude to learn new software applications.

PHYSICAL DEMANDS:

· While performing the duties of this job, the employee is regularly required to be sitting, walk and use hands and fingers, handle or feel, frequently required to talk or hear, reach with hands and arms, climb or balance, stoop, kneel and crouch.

· Specific vision abilities required by this job include close vision.

· The employee must be willing and able to travel to USA.

· Ability to use special protection devices for ears and eyes at the same as gloves for hands.

· Employee may be required to remain stationary for extended periods of time.

· Employee may occasionally be required to traverse through office and/or manufacturing locations.

· Employee will frequently be required to actively listen and exchange information.

· Employee will be required to observe and assess information received via computer.

· Requires use of computer, and telephone.

• NOTE: The above stated duties are intended to outline those functions typically performed by individuals assigned to this classification.  This description of duties is not intended to be all-inclusive or to limit the discretionary authority of supervisors to assign other tasks of similar