Specialist I - Q&r -qa/qe, Edi Q&r
- Respironics Inc
- Not Specified
- Bengaluru
- 4 years ago
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Job Description
Job Title
Specialist I - Q&R -QA/QE, EDI Q&RJob Description
Job Description
Your Profile:
You are used to working in an independent fashion to deliver very demanding assignments to successful completion. You are not afraid to embrace change and act as a change agent to transform organizations and teams in to highly performing units using best practice processes. In past roles, you have used a data driven approach to work objectively across multiple business functions, managing business improvement or change management projects. You have a demonstrable track record in working with senior executives who have sponsored your projects, all the way down to individual contributors who deliver software and services as part of your end project deliverables. You enjoy the challenge of managing through influence across a matrix organization, and have found ways to be successful while operating under budget and other organizational constraints.
Responsibilities:
Perform a wide variety of activities pertaining to compliance with applicable regulatory requirements, quality management system (QMS) maintenance, improvement and harmonization, and quality control and assurance.
- Verification of execution of processes and their deliverables in product creation and subcontracting projects and report the findings to upper management.
- Review and Approval of designated project documentation in product creation projects.
- Advice to product creation projects concerning the definition and implementation of quality assurance activities
- Advise upper management with respect to release for delivery of products
- Support and represent Q&R discipline in Design Reviews, Hazard Analysis brainstorms, Health Risk Assessments
- Initiate, stimulate, and support the implementation of process improvements
- Execution of audits in all business processes and report the findings to upper management
- Support and advise the organization in corrective and preventive actions
- Participate in the maintenance, improvement and deployment of the Quality Management System
- Translates regulations and standards and bring them to consolidation in the organization and the Quality Management System
- Represent the approbation officer in projects and support in the activities to acquire product licenses and approvals
- Participation in and verification off changes to DMR and release orders where Q&R involvement is needed.
- Produces and completes SW Quality Engineering documents under direct supervision.
- Responsible for performing timely, detailed SW Quality engineering tasks like: assessing software designs and reviewing test and other performance data, analyses market feedback, completing or assisting with in root cause analysis and SW Quality problem solving.
- May also provide other SW quality engineering support, including assisting organizational units in addressing SW Quality engineering deficiencies.
Qualifications and Know-How:
- Bachelor or Master degree in relevant knowledge domain, e.g.: Computer Science , electronics, Electrical or information technology.
- Knowledge of relevant external standards for Quality Management Systems for medical devices (e.g. ISO13485, ISO 14971, MDD, 21 CFR Parts 803,806, and 820, ISO 9001)
- Knowledge of (software) processes and procedures
- Qualified Auditor of Quality Systems ( Preferable)
- Good skills in reporting, both in writing and oral
- Fluent speaker and writer in English
- Project management knowledge and skills.
- Knowledge of product creation and (software) development methods & tools
- Experience in using problem solving tools
- Knowledge of external regulations and standards relevant for our products
- Ability to translate legal/Regulatory requirements in to procedures and instructions
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Employement Category:
Employement Type: Full timeIndustry: Quality ControlFunctional Area: project managementRole Category: HeadRole/Responsibilies: Specialist I - Q&r -qa/qe, Edi Q&rContact Details:
Company: Respironics IncLocation(s): Bengaluru+ View Contact
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Respironics Inc
Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with...
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