Senior Quality Engineer

Location

Secunderabad | India

Job description

• In this exciting role as senior reliability engineer in Cardio Vascular portfolio, you will provide key technical expertise and leadership with in the Cardiac Rhythm Management (CRM) operating unit .
• You will have responsibility for supporting post-market surveillance activities including analyzing product performance data, authoring risk assessments and technical reports, and support quality issue investigation/management to improve product performance for implantable products (Pacemakers, Defibrillators, and Leads).
• The CRM operating unit offers high power devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.

As a senior reliability engineer , you will:

Responsibilities may include the following and other duties may be assigned.

Provide reliability and engineering skills to analyze, debug, and as necessary propose design changes to improve system and/or process reliability.

Lead risk analysis studies of design and processes to understand how potential quality issues may be contributing to product quality or patient safety risk.

Authoring risk assessments and technical reports to document analysis results or quality impact.

Provides or directs verification and validation of device system requirements, traceability, and testability.

Conducts evaluation of finished product systems including requirements, design, development, documentation, integration, test, verification, and validation. Interpret and decompose system and product requirements, verify compliance.

Make recommendations on risk management file updates and collaborate with the risk file owner on the execution of the updates

Complete risk assessments related to product nonconformances and performance trends associated with product released to the field.

Must Have: Minimum Requirements

Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 8 to 12 years of work experience.

Strong communication skills, both oral and written.

Ability to comprehend principles of engineering, physiology and medical device use.

Comfortable working with international and multi-cultural department and groups in different time zones .

Experience in risk management or reliability engineering

Accurate and delivers quality work, with a sense of urgency.

Ability to work well under pressure and maintain positive, enthusiastic attitude.

Ability to work in a fast-paced environment .E agerness to learn and expand responsibilities & accountablity .

Good interpersonal skills.

Experience in root cause investigations and assessing risk impact of proposed design changes

Experience supporting production electrical test requirements and development of manufacturing electrical test applications.

Experience with 21CFR820, ISO13485, and ISO14971

Experience with design, verification, and validation of Class III medical devices or similar regulated product

Demonstrated ability to perform data analysis using statistical techniques and reliability tools.

• Ability to work effectively in a team environment and build strong working relationships.
• ASQ certification CQE,CRE

Job tags

Salary