Job Description
Job description
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Summary
Performs the coordination and preparation of internal and external audits and compliance in accordance with regulatory standards. Collaborates with clients to develop positive and proactive approaches to regulatory compliance. Participates in good laboratory practices training of functional areas and assists in the development of training sessions. Ensures that privacy and security standards are met and adhered to. May coordinate activities and assist with interactions during regulatory agency inspections. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. Assists with the corrective action implementation. May coordinate investigator site and clinical supplier vendor audits.
Job Description
We are looking for a Design Quality Engineer for X-ray Imaging Components/Technology business based in Pune as part of global collaboration to ensure compliance with ISO Standards (e.g. ISO 13485, ISO 14971, IEC 60601, IEC 62304) and regulations (e.g. 21 CFR 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/ Medical Device Regulation (MDR), MDSAP country jurisdictions, China, India). This position will collaborate with a 3-person team in the Salt Lake City, Utah, USA, and is expected to work within the same working hours as the rest of the Salt Lake City team (mountain time).
Your Role:
• Apply knowledge of risk management to ensure a risk-based approach for design and process activities
• Review and approve engineering change orders
• Support customer requests (internal and external)
• Support new product introduction for Sources and Detectors
• Maintain and update technical files and risk management files to comply with global regulations
• Participate in addressing audit findings
• Support internal audits and external audits by regulatory agencies, as required.
Your Profile:
• Bachelor's Degree in life sciences, preferably in Electronic or Mechanical engineering
• Minimum of 3 years of work experience with a focus on design control, risk management, and verification and validation.
• 2+ years of global experience in regulatory affairs or quality assurance medical device, aerospace, defense or similarly regulated industry
• Background with Medical Devices (ISO 13485), Electrical Medical Devices (ISO 60601), Risk Management ISO 14971, or Pharmaceutical.
• Expertise and understanding to analyse the meaning of regulations for the business.
• Understanding of safety requirements in this industry context.
• Understanding of Quality Assurance management and experience in reviewing engineer change orders.
• Basic knowledge of ERP systems and Microsoft software.
• Strong verbal and written communication skills; ability to present issues, plans and objectives. Excellent organizational, problem solving, and analytical skills
• Fluent communication in English.
• Ability to lead priorities and workflow versatility, flexibility, and a willingness to work within constantly evolving priorities
• Ability to collaborate with global team members
Additionally valued qualities:
• Experience with the application of Data Science and Advanced Statistical Techniques
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304, FDA’s General Principles of Software validation.
Passion for development of new technologies, including the ability to apply design controls to emerging technologies
Time Type:
Full time
Job Type:
Regular
Work Shift:
N/A
Pay Rate Type:
Salary
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability
