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Senior Quality Engineer - Design Assurance
SGTC India
posted 4mon ago
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Job Description
- We are looking for a driven and detail-oriented individual that has a passion for Quality in Product Sustenance
- We need you to be an advocate for sustain quality into our designs
- You will be joining a team of self-motivated, independent and creative thinkers, we work together and across function ensuring product excellence
- Our team works within the Design Assurance function, but your role will have significant interaction with PD, Marketing, Regulatory and Operations
- As a Senior Quality Engineer, Design Assurance you will lead risk management processes and design control activities for product sustenance
- Being a part of this team means that you are working cross functionally to drive our company s mission and strengthen the Stryker brand
- You should love solving novel problems in fast paced and stimulating environment
What you will do:
- Working effectively with respective cross functional stakeholders in product sustenance and assessing health risk
- Own Risk assessment deliverables and review associated design controls
- Strong hold in verification and validation activities with a rigor to drive design philosophy
- Data analysis and use statistical analysis to drive and make inform decisions.
What you need-
- Minimum of 6+ years experience in risk management, testing and analysis ideally in a strongly regulated environment such as medical device, military or aerospace industry
- Preferably bachelors Degree in Mechanical or Biomedical Engineering or equivalent
- Experience in risk management activities in product sustenance teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
- Experience in the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
- Participation in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
- Influential partnership with R&D to drive safety and performance during change
- Previous experience in data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
- Effective communication and previous experience in implementing compliance regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.
- Working experience in medical device industry is preferred.
- Good knowledge with ISO 13485, ISO 14971, 21 CFR Part 820 standards
- Experience in working in highly engaged teams
Employment Type: Full Time, Permanent
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