Capgemini
DQA
Job Description
DQA JD
Pune Location
- Design Quality Assurance
Key Responsibilities:
- Be a part of core project team and support the quality engineering across the entire development cycle
- Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects.
- Lead the development and implementation of design verification and validation plans with project design lead.
- Lead the development of Critical to Quality (CTQs), design input and output documents.
- Lead the fixture qualification and test method validation.
- Participate and implement tools like Design of Experiments (DOE’s), FMEA sessions, Risk Management and ensure compliance to CTQ’s and safety requirements.
- Manage electronic document control and version control on all project related documents.
- Ensure adherence to the quality systems and design assurance SOPs.
- Lead usability, reliability, testing, verification and validation testing – internal and local vendors.
- Provide statistical testing and reliability plans.
- Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.
- Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable).
- Co-Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
- Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed quality.
Qualification and Experience:
- Bachelors (or higher) degree in engineering with preference mechanical engineering.
- 5-9 years of experience in medical device quality engineering.
- Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation.
- Sound understanding of medical device regulatory requirements for Class II and III medical devices.
- Project planning – resourcing, timelines, quality and budgets.
- Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis).
- Preference for candidates with CQE certification or similar training and experience
- Proficient in project management tools like MS project.
- Experience in GD&T
- Well versed with statistical analytical techniques and s/w tools like MATLAB, MINITAB.
Jobs at Pune
Amazon
Software Development Engineer, AFFS…
Freshers/Experienced
Pune, Maharashtra
Last Date: July 23, 2024
KPMG
Managed Services Employee Vetting &…
KI Professional
Pune, Maharashtra
Last Date: July 10, 2024
Amazon
Software Development Manager, AFFS,…
Freshers/Experienced
Pune, Maharashtra
Last Date: July 23, 2024
KPMG
Technology Enablement SAP-FI Senior…
KI Professional
Pune, Maharashtra
Last Date: July 10, 2024
More Jobs at Capgemini
Capgemini
SAP ISU FICA | 4 to 12 Years | PAN …
Experienced
Noida, Uttar Pradesh
Last Date: July 10, 2024
Capgemini
Workday Reporting | 6 to 9 Years | …
Experienced
Bangalore, Karnataka
Last Date: July 24, 2024
Capgemini
AWS Lamda | 4 to 9 Years | Pan Ind…
Experienced
Bangalore, Karnataka
Last Date: July 17, 2024
Capgemini
Senior Network Engineer
Experienced
Chennai, Tamil Nadu
Last Date: July 24, 2024
Capgemini
e-Learning Developer | 7 To 9 Years…
Experienced
Noida, Uttar Pradesh
Last Date: July 17, 2024
Capgemini
SAP BASIS HANA ADMIN | 6 TO 12 YEAR…
Experienced
Mumbai, Maharashtra
Last Date: July 17, 2024
Capgemini
ANALOG LAYOUT | 4 TO 6 YEARS | BENG…
Experienced
Hyderabad, Telangana
Last Date: July 17, 2024
Capgemini
T24 Data Migration Developer | 6 to…
Experienced
Chennai, Tamil Nadu
Last Date: July 24, 2024
Capgemini
Azure .Net Developer | 4 to 6 years…
Experienced
Bangalore, Karnataka
Last Date: July 10, 2024
Capgemini
Automation Lead | 15 yrs- 20 yrs | …
Sr Hires
Pune, Maharashtra
Last Date: July 17, 2024
Capgemini
SAP Life Sciences Principle Archite…
Sr Hires
Mumbai, Maharashtra
Last Date: July 24, 2024
Actively Recruiting Companies at Pune, Maharashtra