Job Description
In this role, you have the opportunity to
The Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle. The Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes. Opportunity to learn End to End product development as Responsible Quality representative driving compliance throughout Product life cycle.
You are responsible for
- Acts as advisor to subordinates to meet schedules and/or solve technical problems
- Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
- Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
- Provides effective oversight of the execution of the Quality Plan ,Reliability plan , any risk Risk Management activities
- Oversight of all design related activities during the product/system lifecycle
- Independently produces and completes Quality Engineering Documents
- Responsible for performing timely, quality engineering tasks like: Assessing quality plan, assessing product designs and reviewing test and other performance data, analyses market feedback, lead root cause analysis and quality problem solving.
- Performs independent technical assessment on product quality performance
- May also provide other quality engineering support, including assisting organizational units in leading resolution of quality engineering deficiencies
- Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
- Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone
- Ensures the DHF is adherent to the required processes & compliant throughout the project phases as documented in Project Plan.
- Interaction with partner counterparts if applicable. Coordinating for project Stage reviews and Audits. Active participation in development process.
- Supports stakeholders during the execution of quality system- and product audits and inspections
- Within NPI and Sustaining Projects, support all ongoing Project activities e.g. coordinates Quality Norm planning activities, reviews and approves design deliverables and guides the Project Team regarding open Process/Quality questions.
You are a part of
You will become part of the Quality organization, supporting the quality management of MR Systems.
To succeed in this role, you should have the following background, basic skills or experience
- B.E/B.Tech or Masters in Engineering and over 10 years of experience. Have experience in medical industry or high regulated industry (preferred)
- Strong quality assurance management experience
- Strong design control and new product development experience
- Strong statistical and analytical abilities (e.g. design for six sigma, design for reliability)
- Professional knowledge in the area of ISO 13485, FDA 820, ISO14971, FDA/MDR/MDSAP
- Professional knowledge in product safety standards (e.g. IEC60601, IEC62366 Usability, etc)
- Strong communication, problems solving and continuous improvement.
- Fluent English both in writing and speaking.
- Strong Influence Skill, Presentation Skill and Dispute solving Skills.