What are the responsibilities and job description for the Document Control position at Precision Edge Surgical Products Company LLC?
Precision Edge Surgical Products Company LLC
Come join a team where People make the difference! As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.
Review and approval of documents prior to use, including managing the Document Change Request process (ensuring accuracy of document content, revision levels are accurate, and documents are available at each point of use)
High School (minimum)
Experience with Quality Management System and Good Documentation Practices
Experience auditing to or understanding of FDA QSR (21 CFR Part 820) and ISO 13485
Demonstrated proficiency in Microsoft Office including Word and Excel and Adobe Acrobat
At least two years functioning as a Document Control Associate at Precision Edge or equivalent experience
Essential Functions, Knowledge And Competencies
Self-directed and works well under minimal supervision
Professional, well-organized, and eager to learn and be challenged
Must be flexible and able to adapt to changes in priorities
Strong written and oral communication, prioritization and organizational skills and detail oriented
Strong interpersonal skills and ability to work with others in a positive and collaborative manner
Provide strong leadership, set high standards and provide coaching to direct reports
Promotes team-based environment, positive atmosphere, open door policies and a harassment free work environment
Ability to lift 50 pounds
Prolonged periods of sitting at a desk and working on a computer
Responsibility/Authority
Review and approval of documents prior to use, including managing the Document Change Request process (ensuring accuracy of document content, revision levels are accurate, and documents are available at each point of use)
Responsible for the identification, storage, security and integrity, retrieval of QMS records; this is including scanning of records ensuring verification of retrievability and readability, as well as confirmation of associated data inputs to Global Shop (ERP System) where required and the disposal of records when necessary
Responsible for release of product, ensuring a complete review of shipping documentation for accuracy prior to shipment release to the customer and coordinating follow-up activities for any escaped documentation errors to the customer
Serve as the back-up personnel for the management of the Change Order process. This includes managing the activities associated with the initiation of Change Orders, accuracy of Change Orders, ensuring the Change Orders are appropriately routing during the pre-approval and post approval phases and timely completion of tasks associated with Change Orders.
Responsible for coordinating & directing Document Control Associate priorities & schedules; ensuring timely and accurate completion of those activities
Maintain Certified Internal Audit status to perform audits to confirm quality management system compliance when necessary. Assist in routine upkeep of the audit schedules.
May be required to participate and contribute to registrar and customer QMS audits
Train & Mentor Document Control personnel and others when necessary
Authority to sign Document Change Requests on the behalf of the Compliance Manager is not available to ensure timely release of documents.
Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.
We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.
Come join a team where People make the difference! As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.
Review and approval of documents prior to use, including managing the Document Change Request process (ensuring accuracy of document content, revision levels are accurate, and documents are available at each point of use)
High School (minimum)
Experience with Quality Management System and Good Documentation Practices
Experience auditing to or understanding of FDA QSR (21 CFR Part 820) and ISO 13485
Demonstrated proficiency in Microsoft Office including Word and Excel and Adobe Acrobat
At least two years functioning as a Document Control Associate at Precision Edge or equivalent experience
Essential Functions, Knowledge And Competencies
Self-directed and works well under minimal supervision
Professional, well-organized, and eager to learn and be challenged
Must be flexible and able to adapt to changes in priorities
Strong written and oral communication, prioritization and organizational skills and detail oriented
Strong interpersonal skills and ability to work with others in a positive and collaborative manner
Provide strong leadership, set high standards and provide coaching to direct reports
Promotes team-based environment, positive atmosphere, open door policies and a harassment free work environment
Ability to lift 50 pounds
Prolonged periods of sitting at a desk and working on a computer
Responsibility/Authority
Review and approval of documents prior to use, including managing the Document Change Request process (ensuring accuracy of document content, revision levels are accurate, and documents are available at each point of use)
Responsible for the identification, storage, security and integrity, retrieval of QMS records; this is including scanning of records ensuring verification of retrievability and readability, as well as confirmation of associated data inputs to Global Shop (ERP System) where required and the disposal of records when necessary
Responsible for release of product, ensuring a complete review of shipping documentation for accuracy prior to shipment release to the customer and coordinating follow-up activities for any escaped documentation errors to the customer
Serve as the back-up personnel for the management of the Change Order process. This includes managing the activities associated with the initiation of Change Orders, accuracy of Change Orders, ensuring the Change Orders are appropriately routing during the pre-approval and post approval phases and timely completion of tasks associated with Change Orders.
Responsible for coordinating & directing Document Control Associate priorities & schedules; ensuring timely and accurate completion of those activities
Maintain Certified Internal Audit status to perform audits to confirm quality management system compliance when necessary. Assist in routine upkeep of the audit schedules.
May be required to participate and contribute to registrar and customer QMS audits
Train & Mentor Document Control personnel and others when necessary
Authority to sign Document Change Requests on the behalf of the Compliance Manager is not available to ensure timely release of documents.
Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.
We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.
