Careers

SUMMARY:

• The Document Control Coordinator will ensure that the documents are properly controlled in compliance with company procedures and regulatory requirements. The Coordinator is responsible for ensuring released documents are accurate and complete. The Coordinator is responsible for the change control process, document distribution, archiving and retrieving. As a part of Document Control, the Coordinator is also responsible for training documentation. They will communicate the company’s core values of Quality (following the quality program), Attitude (optimistic and helpful), and Attendance (be here every day and on time) throughout the organization.

REPORTS TO:

• Quality System Management

HOURS:

• 7:00 AM – 3:30 PM – includes 0.5 hour of unpaid lunch

FLSA STATUS:

• Non-Exempt

REFERENCES:

• Technical and quality infrastructure
• IQMS Database

QUALIFICATIONS

• Zero to five years of experience working in a regulated industry, such as medical devices or aerospace.
• High School Diploma or GED.
• Proficient with Microsoft Office software, especially Excel and Word.
• Some knowledge of FDA Quality System Regulation (QSR), ISO 13485, and associated standards preferred.
• Some experience with inspection equipment and methods preferred.

COMPETENCIES:

• A technical degree or equivalent experience is required, with preference to those with some administrative or project management background.
• Team player with flexible attitude and ability to prioritize workload and handle multiple tasks/deadlines within a fast-paced environment.
• Ability to adhere to all processes and procedures.
• Highly organized, attention to detail, self-directed, self-motivated.
• Some technical writing experience.
• Experience formatting documents in MS Word, managing information and data in Excel spreadsheets, and summarizing and presenting information and data in MS Power Point.
• Ability to write and comprehend instructions, short correspondence, and memos in English. (Spanish is a plus.)
• Ability to communicate effectively with all members of the company from most senior management to production line employees.
• Ability to solve practical problems.
• Ability to work in a fast-paced environment and meet deadlines.
• Some knowledge of production and inspection processes is desired, including knowledge of good manufacturing and good documentation practices.
• Motivating, proactive and having ability to promote / create a positive and productive work environment.
• Have conciliatory skills in human conflicts.
• Experience with writing procedures or policies.
• Familiar with a Quality Management System (such as ISO 13485) or other regulated environments.

COMPUTER SKILLS:

• Good working knowledge of navigation and use of the Windows operating system in a networked environment.
• Strong understanding of the use of some Microsoft Office Tools such as: Outlook, Word, Excel, Power Point.
• Basic knowledge to read and interpret charts, graphs, and tables of information.
• Aptitude to learn new software applications.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Follow and work in accordance with company policies and procedures to ensure Quality System and regulatory requirements are met in an ethical manner.
• Maintain, update and archive company documents and records in accordance with company procedures; coordinate the preparation, approval, and implementation of these documents as well as archiving and retrieving as needed.
• Maintain security, order and cleanliness of document control area and documentation files.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Provide interpretive assistance to all departments regarding these documents.
• Write and/or edit procedures, work instructions, or policies to ensure compliance with current Quality System and regulatory requirements with accuracy and attention to detail while meeting commitments on time.
• Ensure accuracy of redlines, redactions, and documentation associated with document change process.
• Assist with training and support organization in the proper use of Word, Excel, and other document related software to ensure proper document formatting and consistency in documentation within the company.
• Monitor external standards that are used within the organization and ensure new revisions are reviewed and maintained within the organization.
• Manage document archival and retrieval services. This includes services to confidentially shred company documents and provide off-site storage.
• System administrator for training database maintaining training documentation to ensure evidence of meeting training requirements is readily available.
• Participate in internal, external, or supplier quality audits, providing timely retrieval of all requested controlled documents.
• Assist with the maintenance of Quality Metrics. Provide support as needed for metrics in Management Review.
• Acts as a consultant for areas related to their expertise.
• Participate and assist as a part of the Internal Audit team as required.
• Maintain and organize training records of all individual employees to track progress and completion.
• Complete and return all customer requested surveys in a timely fashion.
• Manage work instructions of document control processes, Master Document List, Formatting, etc.
• Maintain customer Quality Agreement log.
• Review training needed for employees and alert supervisors/managers of missing training documentation.
• Adjust employee’s active/inactive status within the IQMS system per H.R. input.
• Scan and validate completed DHR documents after gathering any missing information, signatures, etc.
• Prepare and distribute basic training documents to trainers then gather and record information within employee records.
• Other duties as assigned, verbal and written.
• Abide by the day-to-day Safety Standards for personnel by utilizing mandatory Safety Procedures.
• Review DHR records for accuracy and adherence to current cGMP requirements. Scan completed DHR records after gathering any missing information, signatures, etc.
• Create Certificates of Conformance to meet Wytech and customer requirements
• Communicates and promotes the Wytech Quality Policy: Wytech Industries, LLC is committed to providing products that meet customer and applicable regulatory requirements for the medical device industry. We hold ourselves accountable to this commitment. Wytech’s Quality Management System (QMS) is foundational to our business and our supply chain partners are an extension of Wytech. Continuous improvement allows Wytech to ensure we meet the needs of our business and adapt to changing quality expectations and applicable regulatory requirements.

PHYSICAL DEMANDS:

• While performing the duties of this job, the employee is regularly required to be sitting, walking 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.
• Endure extended amount of computer screen time and sitting.
• Specific vision abilities required by this job include close vision, (vision 20/20 is a plus).
• Required use of PPE such as safety glasses, ear plugs, steel toed shoes, and gloves.

This job description is not intended to be an exhaustive list of all skills, duties, responsibilities, or qualifications associated with this position. While this list is intended to be an accurate reflection of the current job, the company reserves the right to revise the functions and duties of the job or to require that additional or different tasks be performed when circumstances change. Employees are held accountable for all duties of position.