Senior Specialist, Quality Management Systems
Company: Katalyst Healthcares & Life Sciences
Location: Mahwah
Posted on: June 23, 2022
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Job Description:
Job DescriptionResponsibilities: Lead and participate in local
and global change management projects, ensuring appropriate
outcomes and compliance, particularly in those areas related to
Quality Systems. Champion continuous process improvement throughout
Quality Systems/Change Management and the rest of the Stryker
organization. Supports QMS compliance with the appropriate internal
and external regulatory requirements (including but not limited to
Site, Division, Corporate, FDA, ISO, MDD, and individual country
requirements). Ensure optimum state of QMS for current and future
business needs. Identify and deliver strategic and futuristic
improvements in areas of responsibility. Oversee and execute
development and/or modification of Stryker's QMS. Support
Management Review and Quality Planning Review and related forums.
Assess and quantify requirements for QMS to optimize organizational
structure in areas of responsibility. Ensure GMP and GDP compliance
within Quality organization. Provide guidance for the development,
maintenance, and improvement of policies and procedures to increase
the efficiency and effectiveness of the QMS. Ensure development and
delivery of QMS training in areas of expertise. Provide
individualized mentoring for team members. Contribute to the
development, maintenance, and improvements of policies and
procedures. Implement best-in-class practices and benchmark against
industry leaders and regulatory requirements. Liaise and
communicate with notified bodies to manage certification changes.
Ensure QMS reflects actual activities, business needs and supports
NPD requirements. Engage in relevant QMS IS discussions. Basic
project management understanding. Key contributor to QMS business
process(as) and understand IS system support requirements. Support
internal and external quality system audits. Understands system
integration. Support IS change control assessment and
approval.Requirements: BS in a science, engineering, business or
related discipline. 3 years experience in manufacturing environment
or equivalent preferred. Experience in regulated environment and
interaction with regulatory agencies required. Thorough knowledge
and understanding of US and International Medical Device
Regulations. Strong knowledge of Quality Systems (CAPA, audits,
Management Review, Quality Planning, etc.) Strong communication,
project management and influencing skills. Ability to plan,
organize, and implement multiple concurrent tasks. Strong
interpersonal skills, written, oral communication and negotiations
skills. Must demonstrate the ability to effectively communicate
up/down and across different levels of the organization. Analytical
and problem-solving capabilities with the ability to draw insights
from data quickly and to define executable actions. Demonstrated
ability to work in cross-functional team environments. Basic
understanding of compliance risk situations. Computer literacy.
Some travel may be required.
Keywords: Katalyst Healthcares & Life Sciences, Paterson , Senior Specialist, Quality Management Systems, Executive , Mahwah, New Jersey
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