4+ QMS Jobs in India
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Job Title : Medical Device Engineer
Location : Bangalore / Pune
Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation
Notice Period : Immediate to 1 week
Interview Process : L1-selected candidates will undergo a customer interview
Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.
Key Skills & Knowledge :
- Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
- Experience with FDA and EU MDR regulatory requirements
Responsibilities :
- Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
- Analyze and implement design changes, assess impact, and update documentation accordingly
- Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
- Assess compliance with applicable standards and regulations
- Define CTS/CTQ parameters and actively participate in design reviews
- Follow QMS guidelines and manage changes through PLM.
C++Skills: C++, QT, UI, TCP/IP, HTTP/HTTPS, Networking Protocols
Branch: Computer Science (B.E/B.tech)
Location: Bangalore (Work from Office)
Experience- 1-5yrs
At Prolifics, we are currently implementing multiple solutions on PCQA Manager for our development centre in India. This position would be based out of Hyderabad location and is a permanent position.
If you are looking for a high growth company with rock-solid stability, if you thrive in the energetic atmosphere of high profile projects, we want to talk to you today! Let’s connect and explore possibilities of having you onboard the Prolifics team!
Job Title: Manager - PCQA
Primary skills: 7+ years of experience
Location: Hyderabad
Educational Qualification: B.Tech/BE/M.Tech/MCA/M.Sc
JD:
The PCQA Manager is a key role to support the process improvement (CMMI V2.0) initiative that will help assess the quality of the software delivered by a growing Software Development Company to its customers. This role will be part of the PCQA team, which helps the organization sustain SEI CMMI DEV Level 5, upgrade to CMMI V2.0 and support other methodology related initiatives.
- Lead the PCQA team and be flexible to take up assignments within the team such as Coaching, Auditing, implementation, process improvement projects, QMS process improvements, agile practices implementation etc.
- Mentor the team in the development and implementation of QMS aligning to CMMI V2.0 within the organization across geographies
- Identify improvements opportunities in the existing policies, processes, procedures, templates and metrics for the organization
- Define and utilize metrics and reports to manage quality efforts
- Prepare and conduct quality assurance product reviews and prepare projects teams ready for process audits according to the audit plan
- Sound understanding of Process Frameworks/Methodologies like CMMI-Dev, SVC, AGILE SCRUM etc.
- Good understanding of various software development life cycles
- Ability to influence and drive delivery with global senior management
- Attention to detail while keeping a global perspective, willing to deep-dive for data analysis
- Good communication and interpersonal skills to interact with global stakeholders
- Very good understanding of Information security concepts and implementation experience of ISO 27001 and other security standards is a value add
About us:
Prolifics Corporation Limited is a Global Technology Solutions Provider with presence across North America (USA and Canada), Europe (UK and Germany), Middle East & Asia. In India, we have off shore development centers: 3 in Hyderabad & 1 in Pune.
For more than 40 years, Prolifics has transformed enterprises of all sizes including over 100 Fortune 1000 companies by solving their complex IT challenges. Our clients include Fortune 50 and Fortune 100 companies across a broad range of industries including Financial Services, Insurance, Government, Healthcare, Telecommunications, Manufacturing and Retail. We rank consistently in Dream Companies to Work For and Dream Employer of the Year ranking from World HRD Congress, ranked 7 in 2019.
We encourage you to visit us on www.prolifics.com or follow us on Twitter, LinkedIn, Facebook, Youtube and other social media to know more about us.
What you will do:
- Working closely with the external auditors to achieve common goals
- Conducting Enabling Service Audit (HR, Admin, IT) once in 6 months for the verification of ISMS & QMS Standards
- Performing ISMS and Internal Audit
- Being part of the external Audits (ISMS, QMS & CMMI)
- Managing of implementation of ISMS
Desired Candidate Profile
What you need to have:- Strong communication and team building skills with proficiency at grasping new technical concepts quickly and utilizing the same in a productive manner
- Experience in ISO27001, Internal Audits, CMMI
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