Medical Device Auditor

3 weeks ago

Bengaluru, India Underwriters Laboratories Inc. Full time

:
At UL, we know why we come to work.:
Thousands of us around the world wake up every day with a common purpose: to make the world a safer, more secure and sustainable place. Science is in our DNA; we are endlessly curious and passionate about seeking and speaking the truth. We take delight in knowing that our work makes a meaningful contribution to society, and we are proud that our culture is centered on integrity, collaboration, inclusion, and excellence. UL stands at the forefront of technological advancement, and we are continually challenged to find new ways to foster innovation and positive change. Satisfying? Yes. Exciting? Absolutely

As our global footprint continues to grow, we are looking for a Lead Auditor to join our Medical Devices team to service our clients in India.

What you’ll learn & achieve:

- Support regular quality system and technical audits, including CE unannounced audits.
- Provide timely Audit Reports and customer Corrective and Preventive Action analysis and responses.
- Subject to training and qualification milestones, perform key Quality Management System audit activities to support safe products to market.
- Support Competent Authority activities on as needed basis e.g., Competent Authority audits of UL.
- Participate in the development of UL requirements and assessment methods. Integrate continuous improvement concepts into all aspects of the job.
- Provide guidance and support to customers as required. Participate in client training and customer forums.
- Performs other duties as directed.

What makes you a great fit:

- University or a technical college degree or equivalent qualification in relevant studies, such as medicine, pharmacy, engineering, or other relevant sciences.
- Four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing, or research, of which two years shall be in quality management.
- Appropriate knowledge:

- Devices legislation as well as related harmonized standards, CS, and guidance documents
- Risk management and related device standards and guidance documents
- Quality management systems and related standards and guidance documents
- ** Conformity assessment procedures in the listed programs**:

- **MDSAP, ISO13485, MDD/MDR, IVDD/IVDR, Indian Certification for Medical Devices (ICMED) 13485 Scheme, NABCB Accreditation for Certification Bodies, etc.**
- Useful experience may include testing, design and development, manufacturing, quality assurance, or monitoring experiences.
- **Technical experience in active or non-active medical devices, or dental devices, or In-Vitro Diagnostics / blood or tissue products, with a focus on medical device processes and products.**
- Training in auditing techniques enabling them to challenge quality management systems
- Ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out
- ** Ability to travel domestically and internationally (50-75%)**:
What you’ll experience working at UL:

- **Mission**:For UL, corporate and social responsibility isn’t new. Making the world a safer, more secure and sustainable place has been our business model for the last 125 years and is deeply engrained in everything we do.
- ** People**:Ask any UL employee what they love most about working here, and you’ll almost always hear, “the people.” Going beyond what is possible is the standard at UL. We’re able to deliver the best because we employ the best.
- ** Interesting work**:Every day is different for us here as we eagerly anticipate the next innovation that our customers create. We’re inspired to take on the challenge that will transform how people live, work and play. And as a global company, in many roles, you will get international experience working with colleagues around the world.
- ** Grow & achieve**:We learn, work and grow together with targeted development, reward and recognition programs as well as our very own UL University that offers extensive training programs for employees at all stages, including a technical training track for applicable roles.
- ** Total Rewards**:

- Competitive remuneration package with yearly bonus
- Mediclaim scheme for family
- Group Term Life Insurance
- Group Personal Accident Insurance
- Training and Development (provided by UL University).

Learn More:
Working at UL is an exciting journey that twists and turns daily. We thrive in the twists and revel in the turns. This is our every day. This is our normal.

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