
Senior Analyst - Design Quality Assurance
Beckman Coulter is seeking a highly skilled and experienced Senior Analyst for our Design Quality Assurance team. As a global leader in the healthcare industry, we are committed to delivering innovative and reliable products that improve patient outcomes. This role is integral to ensuring the quality and safety of our products through rigorous design control and compliance with regulatory standards. We are looking for a detail-oriented and analytical individual with a strong background in design quality assurance and a passion for improving healthcare. If you are a self-motivated and team-oriented professional with the necessary qualifications, we encourage you to apply for this exciting opportunity.
- Lead the Design Quality Assurance team and provide guidance and support to junior analysts.
- Conduct thorough reviews of product designs to ensure compliance with regulatory standards and internal quality requirements.
- Develop and implement design control processes to ensure the safety and effectiveness of products.
- Collaborate with cross-functional teams including R&D, manufacturing, and regulatory affairs to ensure timely product development and launch.
- Identify and escalate any potential design or quality issues to management and work towards timely resolution.
- Perform risk assessments and develop risk management plans for new and existing products.
- Stay up-to-date with industry regulations and standards to ensure compliance.
- Train and mentor team members on design quality assurance processes and procedures.
- Participate in audits and inspections by regulatory agencies.
- Continuously improve design quality processes and procedures to increase efficiency and effectiveness.
- Communicate with internal and external stakeholders to provide updates on design quality assurance activities.
- Represent the company in a professional manner and uphold the company's values and standards.
- Participate in cross-functional projects as needed to support overall quality objectives.
- Maintain accurate and organized documentation of all design quality assurance activities.
- Adhere to all company policies and procedures, including safety and confidentiality.
Bachelor's Degree In Engineering, Science, Or A Related Field.
Minimum Of 5 Years Of Experience In Quality Assurance Within The Medical Device Industry.
Strong Knowledge Of Fda Regulations And Iso Standards For Medical Device Design And Development.
Experience With Risk Management And Process Improvement Methodologies, Such As Six Sigma Or Lean.
Excellent Communication And Leadership Skills, With The Ability To Lead Cross-Functional Teams And Effectively Communicate With Stakeholders At All Levels Of The Organization.
Risk Management
Quality Assurance
Process Improvement
Project Management
Data Analysis
statistical analysis
Technical Writing
Quality Control
Audit
Root Cause Analysis
Team Leadership
Regulatory compliance
Communication
Conflict Resolution
Leadership
Multitasking
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Analyst - Design Quality Assurance in Bengaluru, Karnataka, India is between ₹ 9,00,000 to ₹ 12,00,000 per year. However, this can vary depending on the specific company, experience level, and skills of the individual.
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Beckman Coulter Inc., is a Danaher Corporation company that develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing.

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