Manager / Sr. Manager, Operations Technical Suppport - Product Support Technical Writing in San Diego California United States

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Summary of Duties and Responsibilities Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments. Our more than 6,000 associates worldwide are driven towards breakthrough achievements in research, product development and the worldwide distribution of healthcare solutions. We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future. There has never been a more exciting time in our company’s history. Visit our website to learn more about the many career opportunities we have available today. _Role The Manager/Sr. Manager, OTS Product Support Technical Writing is responsible for leading a team of Technical Writers in the management of design, editing, change control, compliance, translation, and market support related to new and existing product package inserts; operator’s, training, and service manuals; and online help files. _Essential Duties and Responsibilities Coach and develop team members Lead and actively contribute to the technical aspects of manuals, package inserts, and online help files. Interface with company partners, distributors, and OEMs. Manage relationship with external translation suppliers to achieve high quality, on-time project deliverables Interface with Engineering to complete project deliverables for automated systems Interface with Quality to ensure change control requirements are appropriate and efficient Interface with Marketing to align with corporate initiatives such as branding and business expansion translation needs Successfully collaborate cross-functionally in a GMP and development environment Maketimelydecisionsbasedonaccuratelogic Develop department goals and/or metrics to support department and corporate goals Successfully manage multiple project timelines Allocate department resources to achieve goals Author and revises standard operating procedures, reports, and other related documentation Create area guidelines to enhance department activities Actively manage non-conformance, complaint investigations and CAPA activities within the department Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required Significant experience in successfully managing diverse team environments and one-on-one situations Strong personal, team, and cross-functional leadership skills Strong problem solving skills Strong technical writing skills Working experience with Madcap Flare, Adobe Frame Maker and Acrobat, and Microsoft products. Knowledge of and working experience in project management Experience with online help systems using HTML, XML Knowledge of and working experience with Medical Device Documentation and use of document control systems such as Agile PLM and Oracle ERP systems. Knowledge of and working experience with managing projects with external translation companies Knowledge of and working experience with QSR, EN13485, ISO, US FDA, and related standards and regulations Desired but not required Knowledge of and working experience in expense and budget management Knowledge of risk management processes under ISO 14971 Education 8-10 years of related technical writing and management experience or MS and 6-8 years of related technical writing and management experience. A degree in Technical Writing or a scientific discipline is preferred. Experience 8-10 years of related technical writing and management experience or MS and 6-8 years of related technical writing and management experience. A degree in Technical Writing or a scientific discipline is preferred. Specialized Knowledge Additional Details Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. _Hologic, Inc. is proud to be an equal opportunity employer
Phama Job Categories: 
USA
Quality Control

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