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Senior Manager, Document Services

Company: Getinge
Location: Wayne
Posted on: September 16, 2022

Job Description:

*Senior Manager, Document Services* Wayne, NJ *Together we can make a difference* At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope - just to name a few. A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day. This role will be responsible for the overall management of the document change control process and the accuracy and integrity of Maquet Cardiovascular(CS/VI) and Datascope Corp (CA) site documents, data, and records, to comply with all applicable regulations and quality system requirements. Responsible for aligning the processes and procedures across the multiple quality systems. Works with IT as the subject matter expert on system changes. *Job Responsibilities and Essential Duties: ** Responsible for the Documentation Services function that supports VI, CS, and Cardiac Assist in the three NJ sites and Pleasanton, CA. This can include a mix of direct and dotted-line employees at multiple Getinge sites.
* Is responsible for the Documentation Services budget, staffing, hiring, employee performance, development plant, etc.
* Windchill and TrackWise Business Process Lead. Works with IT as the process expert and process owner for system changes.
* Responsibilities for providing support for QMS system, Internal and External audit preparation and support, and leading CAPA's.
* Assures compliance with internal business process requirements in addition to external regulations.
* Leads global Doc Services initiatives (example: process harmonization activities, TrackWise and Windchill updates and upgrades.)
* Manages Front and Backroom activities during third party audits and inspections as well as support/lead audit responses as needed.
* Subject Matter Expert for documentation. TrackWise and Windchill related questions during internal and third party audits.
* Develops Document Services staff and creates succession plans with Document Services.
* Manages the distribution of controlled documentation and oversee the successful archiving of controlled documentation and records.
* Responsible for continuous improvement of business processes.
* Assures that shared documentation and "corporate" documentation is adequately controlled and shared among Getinge sites (including "MESY-"documents).
* Maintains a Quality Records Room of hard copy data for validations, weaving patterns, oven software, legacy change requests, current site documentation (up to date SFP - as a contingency), laboratory notebook issuance and maintenance; design history files.
* Facilitate the annual roll up of labor and overhead hours for routings with the Finance and Industrial Engineering department.
* Work with Manufacturing managers, supervisors and leads to facilitate Shop Floor Paperwork changes and corrections as needed and to implement production order changes.
* Partners with Training department on Good Documentation Practices training. *Minimum Requirements: ** Bachelor's degree or equivalent experience.
* Demonstrated 4 years' experience supervising employees and building a team is required.
* Must have a minimum of 2 yrs. demonstrated experience supervising employees across multiple sites is required.
* Must have at least 10 years in Document Services.
* Must have strong written and verbal communication skills with a demonstrated proficiency in computer based word processing. Prior experience with database management is highly desirable.
* Demonstrated ability to manage projects and utilization of problem solving is required.
* Prior experience training in a professional environment is highly desirable. Strong interpersonal and communication skills.
* Excellent quantitative and analytical skills.
* Ability to prioritize tasks in a fast-paced environment.
* Intermediate skills using Microsoft Office products such as Outlook, Word, Excel and Power Point *Excellent Opportunity to join an industry leader! Excellent Benefits!... Dental, Health, Vision, Life and 401(k) and more!**Interested candidates please send your resume.*_Getinge is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law._ We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world's most desired medtech company. INDNM Job Type: Full-time Benefits:
* 401(k)
* Dental insurance
* Health insurance
* Life insurance
* Vision insurance
* Monday to Friday Work Location: One location

Keywords: Getinge, Wayne , Senior Manager, Document Services, Executive , Wayne, New Jersey

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