Be responsible in providing a wide variety of administrative support to the Quality Assurance, Engineering, and Production Department areas.RESPONSIBILITIES
Processing of engineering changes notices (ECNs).
Documentation filing and storage.
Supporting quality engineering activities and tasks.
Establish and maintain appropriate documentation as required for quality assurance activities.
Ensure document control processes are followed, and documentation is up to date.
Maintain logs/lists/catalogues for controlled documents, technical documents, and master documents requiring routing, signatures, and approvals.
Coordinate and assist in the review and revision of control documents to ensure completeness and coordinating timely distribution of controlled documents.
Verify document numbers, revisions, and original signatures are in compliance.
Assemble and prepare original control documents for distribution as directed by management.
Assist management team in maintaining accurate and timely issuance of control documents; comply with guidance provided to ensure consistent and reliable services to parties requiring document control interface.
Perform miscellaneous administrative support functions associated with this position as appropriate and as directed by management.
Maintain control of document and records to establish the system.
Ensure the safety and security of all records.
Issuing export certificates for shipments
Ensure that all company documents are up to date, organized.
Perform changes to core documents to align processes with current regulations.
Assist with technical edits of engineering documents.
Identify and develop improvements in the quality system.
Perform other duties as assigned.
REQUIREMENTS
EDUCATION:
University degree completed or advanced student in engineering, business administration or a related field (required).
EXPERIENCE:
Minimum 1-2 years technical edit and document control experience (required)
Minimum 1.5 years of experience within a medical device manufacturing environment (required)
Proficiency in Microsoft Office Suite, including MS Word, Excel, and PowerPoint (required)
PREFERRED QUALIFICATIONS:
4 years of document management and filing experience (preferred).
POSITION SKILLS:
Excellent written and oral communication skills.
Must have superb organizational skills.
English communication skills (B1 - B2) reading and writing.
Reasoning: Ability to follow detailed procedures with several potential variables. Problem- solving ability and interpretation of events required for practical matters. Creative, innovative solutions to job problems.
Calculations: Addition, subtraction, multiplication, division, decimals and percentages.
Knowledge of various units of measure such as inch, foot, and yard.
Language: Ability to read and understand policies, diagrams, instructions.
Speaking: Ability to convey detailed messages department supervisor and other employees.
Hearing: Ability to receive detailed information through oral communication both in person and via telephone