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Sr. QMS Engineer - Services and Systems
6-9 years
Bangalore / Bengaluru
1 vacancy
Sr. QMS Engineer - Services and Systems
Philips
posted 6d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Partners with applicable stakeholders to: ensure new/existing service offerings are developed in accordance to all regulatory/standard requirements, QMS is properly updated (as applicable) for new tools/systems and ensure all applicable documentation for required verification and validation is completed to ensure ongoing QMS compliance
Your role:
- Partners with Service organization to ensure process to define, develop and deploy service offerings meet all applicable regulations and standards
- Represents QMS/Engineering Change processes and records to regulatory agencies as required
- As applicable, manage all the open Intra-company Quality agreements and Quality plans; accountable for ensuring plans are effectively monitored
- Proactively identifies areas of emerging risk and advises on directions for future areas of analysis/development
- Lead services and systems SW integration for successful onboarding and life-cycle management of SW applications.
- Provide GxP-related quality assurance oversight, guidance, support and interpretation, with an emphasis on software validation, to personnel in their validation efforts, to ensure compliance; recommend appropriate corrective actions where needed.
- Acts as QMS competence expert, coaching and developing skills and knowledge within the QMS team
- Managing the QMS Document Control System, including the Philips Excellence Process Framework for the transformation the business to the Philips Business System in the Philips Integrated IT Landscape.
- Promoting Q&R awareness level as determined within the organization, creates PQMS transformation and manages applicable activities under PQMS governance
- Participates in Quality & Regulatory initiatives as a cross functional contributor
Youre the right fit if:
- 14+ years experience in a similar role (Preferred medical device / Regulated industries)
- Experience in Medical devices, Software Validation, ISO 13485, 21CFR 820, FDA Inspection, QMS Audit
- BTech / MTech / BS /MS
- Self-driven, Goal achiever, Individual with program management experience will help achieve required Goals
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company s facilities.
Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers locations.
Indicate if this role is an office/field/onsite role.
#LI-Hybrid
Employment Type: Full Time, Permanent
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Rating based on 7 Service Engineer
reviews
Anonymous · Engineering
in Pune
I used to like hybrid work(3 days/week). Used to like the flexibility and internal movement opportunities.
Consistent push to come to office for more than 3 days. No skill development, only on the job learning. No global site exposure. Relocation is also not available nowadays to move to sites outside India. Fear of job security is seen owing to business conditions.
Read 7 reviewsService Engineer salary at Philips
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