Senior Specialist, Document Control
Gurugram, Haryana, IN
Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker’s RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
Who we want:
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Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
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Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
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Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
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Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
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Delivers results. A driven player who sets high goals for personal achievement and organizational success. He/she measures success against the best internal and external benchmarks
What you will do:
Job Summary: Lead PLM services globally and provides technical and administrative support to one or more TDP, PDP, sustaining and/or BI projects.
As a document control specialist on the PLM team, you will join a team of ERP engineers that work in a cross-functional, collaborative and blame-free environment. Your role will be responsible for PLM applications and tool development, configuration, customization, upgrade, including implementation and rollout of new releases.
The candidate will be responsible for managing and handling the PLM Support services by properly guiding and monitoring a team of PLM support consultants/engineers. He/She will be mainly responsible for:
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Ensure smooth support in PLM
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Driving efficiency and improvements in our business processes
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System enhancement and development as per customer's needs/requirements
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Required coordination with global PLM/support team
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Regular and frequent interaction with Customers
The candidate should have 6 ~ 8 years of working experience in PLM/PDM domain having worked in the following modules/area:
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Product Development
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Change Management
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Life Cycle Management
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Document Control
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Product Configuration and Variant Management
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PLM > SAP interface and CAD integration will be further value addition.
What You Need
Expertise in PLM. Develop and maintain deep expertise in PLM Windchill document revision control application.
Work with Documentation Services and R&D for adherence to processes and the use of PLM to house Quality System documentation and Quality Records. Work with R&D and others in the organization to report issues, provide input for improvements (through creation or review of Requirements), functional testing during product life cycle and testing for processes involving PLM.
Support PLM Document Control for Stryker R&D Projects. Includes creation of CRs, reviewing/editing documents for revision control in referenced documents, preparing documents for inputting to PLM, maintaining clean DHFs, linking documents and projects to other projects. Range of documentation will be DHF, DMR, Functional, and Journal for PDP projects. For TDP, BI, and SE projects, additional documentation will be supported. May include training others in PLM.
Expertise in the use of PLM as related to Quality System. Knowledge and use of all Quality System SOPs and Work Instructions that must be followed by R&D staff to create and maintain documentation in PLM.
Support of Audit Readiness. Includes Back-Room participation, creation of tools for R&D, pre-audit prep of documents, creating/maintaining PLM infrastructure to support business practices and audit tools (documents, proof-books; linkages), and maintenance of clean DHFs in PLM.
Communicate throughout the Organization. Ensure good communication with R&D Staff and department manager for workload monitoring/prioritization (weekly) and support excellent communication across assigned Core/Extended Teams, including communication among R&D sites and with various GQO team members across GQO sites.
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Minimum Qualifications (Required):
B.S. degree in engineering or applicable technical field (mechanical or biomedical preferred) having 6 ~ 10 years of working experience in PLM/PDM domain
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.
Job details
Date posted: April 7, 2024
Job ID: R514955
Job category: RAQA
Primary location: Gurugram, Haryana, IN
Employee type: Full time
Relocation: No
Work Flexibility: Hybrid or Onsite
Travel:
