Offer summary

Qualifications:

Good knowledge of Medical Devices and Quality Management Systems (QMS) including ISO 13485 and 21 CFR Part 820., Familiarity with ISO 14971 for risk management., Ability to analyze quality and risk-related data effectively., Strong communication skills to work with cross-functional teams..

Key responsibilities:

Ensure adherence to QMS and relevant product standards and regulatory requirements.

Identify gaps in compliance and propose remediation plans.

Evaluate potential risks and check the adequacy of risk control measures.

Analyze quality and risk-related data to identify issues and trends.

Job description

Role: R&D Engineer
Location: Remote
Job type: Full time

Job Description
Good Knowledge of Medical Devices & QMS (ISO 13485, 21 CFR Part 820) and familiarity with ISO 14971,
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

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.

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