Senior Manager, Document Services
Posted on: September 16, 2022
*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
* 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
* Manages Front and Backroom activities during third party audits
and inspections as well as support/lead audit responses as
* 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
* Responsible for continuous improvement of business processes.
* Assures that shared documentation and "corporate" documentation
is adequately controlled and shared among Getinge sites (including
* 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
* Facilitate the annual roll up of labor and overhead hours for
routings with the Finance and Industrial Engineering
* 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
* 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
* 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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