R&D Engineer
Apply NowCompany: Tata Consultancy Services
Location: San Diego, CA 92154
Description:
Must Have Technical/Functional Skills
Good Knowledge of Medical Devices & QMS (ISO 13485, 21 CFR Part 820) and familiarity with ISO 14971,
Roles & Responsibilities
Gap Analysis Support:
Ensure adherence to QMS (ISO 13485, FDA 21 CFR Part 820), relevant product standards, regulatory requirements and ISO 14971.
Identify the gaps and propose a remediation plan
Remediate the files based on the approach mutually agreed upon
Ensure all potential risks are identified and evaluated appropriately
Check for adequacy and efficiency of Risk control measures
Work closely with cross-functional teams, including engineering, Manufacturing, marketing and Medical affairs and integrate inputs
Analyse Quality/risk related data to identify potential issues and trends. This may include post market data/ complaints etc.
Follow good documentation practices and ensure defect free delivery
Generic Managerial Skills, If any
Communicate with the offshore team at India on a day today basis to resolve technical queries by clarifying with the customer and update the progress to customer and offshore Manager.
Salary Range: $120,000-$150,000 a year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
#LI-SP1
Good Knowledge of Medical Devices & QMS (ISO 13485, 21 CFR Part 820) and familiarity with ISO 14971,
Roles & Responsibilities
Gap Analysis Support:
Ensure adherence to QMS (ISO 13485, FDA 21 CFR Part 820), relevant product standards, regulatory requirements and ISO 14971.
Identify the gaps and propose a remediation plan
Remediate the files based on the approach mutually agreed upon
Ensure all potential risks are identified and evaluated appropriately
Check for adequacy and efficiency of Risk control measures
Work closely with cross-functional teams, including engineering, Manufacturing, marketing and Medical affairs and integrate inputs
Analyse Quality/risk related data to identify potential issues and trends. This may include post market data/ complaints etc.
Follow good documentation practices and ensure defect free delivery
Generic Managerial Skills, If any
Communicate with the offshore team at India on a day today basis to resolve technical queries by clarifying with the customer and update the progress to customer and offshore Manager.
Salary Range: $120,000-$150,000 a year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
#LI-SP1