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Home
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Capgemini
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Design Quality Assurance ( DQA ) Professional

Design Quality Assurance ( DQA ) Professional

Capgemini

4 - 7 years

3 - 7 Lacs

pune

Posted:None| Platform:

Apply

Skills Required

ms project statistical tools regulatory compliance regulatory requirements qms emerging technologies quality initiatives regulatory submissions pharmaceutical biomedical engineering pharmaceutical sciences minitab software engineering 168707

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are seeking a highly skilled and experienced professional for the role of

Design Quality Assurance (DQA)

in Pune. The ideal candidate will have a strong background in quality management systems, regulatory compliance for medical devices, and hands-on experience with statistical tools and project management. This role is critical in ensuring product quality and regulatory adherence for Class II and III medical devices.

Key Responsibilities:

Ensure compliance with
ISO 13485
,
ISO 14971
, and other relevant quality standards.
Oversee design assurance, design control, verification, and validation activities.
Support regulatory submissions and audits for Class II and III medical devices.
Utilize statistical tools (e.g., MINITAB) for data analysis and quality improvement.
Apply
Geometric Dimensioning and Tolerancing (GD&T)
in product design and evaluation.
Manage projects using tools like
MS Project
and ensure timely delivery.
Collaborate with cross-functional teams to drive quality initiatives.

Primary Skills (Mandatory):

Professional training/certification in
Quality Management Systems
(ISO 13485, ISO 14971).
Strong understanding of
medical device regulatory requirements
.
Experience with
design assurance/control
,
verification
, and
validation
.
Proficiency in
MS Project
and
statistical tools
like
MINITAB
.
Knowledge of
GD&T
principles.
CQE certification or equivalent training/experience is preferred.

Secondary Skills (Good to Have):

Exposure to
emerging technologies
and
current industry practices
.
Ability to
learn quickly
and work independently with minimal supervision.
Strong
verbal and written communication
skills.
Qualification:
- Bachelors or higher degree in
  Biomedical Engineering
  or
  Pharmaceutical Sciences

Works in the area of Software Engineering, which encompasses the development, maintenance and optimization of software solutions/applications.

1. Applies scientific methods to analyse and solve software engineering problems.

2. He/she is responsible for the development and application of software engineering practice and knowledge, in research, design, development and maintenance.

3. His/her work requires the exercise of original thought and judgement and the ability to supervise the technical and administrative work of other software engineers.

4. The software engineer builds skills and expertise of his/her software engineering discipline to reach standard software engineer skills expectations for the applicable role, as defined in Professional Communities.

5. The software engineer collaborates and acts as team player with other software engineers and stakeholders.

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Design Quality Assurance ( DQA ) Professional

Experience & Salary

Skills Required

Work Mode

Job Type

Job Description

Design Quality Assurance (DQA)

Key Responsibilities:

ISO 13485

ISO 14971

Geometric Dimensioning and Tolerancing (GD&T)

MS Project

Primary Skills (Mandatory):

Quality Management Systems

medical device regulatory requirements

design assurance/control

verification

validation

MS Project

statistical tools

MINITAB

GD&T

Secondary Skills (Good to Have):

emerging technologies

current industry practices

learn quickly

verbal and written communication

Qualification:

Biomedical Engineering

Pharmaceutical Sciences

More Jobs at Capgemini