Modular Medical Inc
Manager of Post Market Surveillance
Modular Medical Inc, San Diego, California, United States, 92189
Job Title:Manager, Post-Market Surveillance
Job Category:Exempt
Department:Quality Assurance
Direct Report:Director of Quality
Location:92127
Travel Required:Up to 20%
Salary Range:$95,000 - $135,000
Position Type:Full-time/Onsite
Job DescriptionEssential Job Functions:
Position responsibilities include, but may not be limited to the following:
Develop and implement comprehensive quality assurance strategies, policies, and procedures that ensure compliance with applicable regulations and standards in the medical device industry.
Collaborate with cross-functional teams, including manufacturing, engineering, regulatory affairs, and operations, to identify and address quality-related issues and drive continuous improvement.
Responsible for quality system improvements for the company to gain certification to the ISO 13485 European standards along with compliance to MDR 2017/745/EU.
Develop quality metrics and monitoring to present on an ongoing basis and feed into Management Reviews.
Act as a quality representative and liaison with the contract manufacturing to ensure compliance with regulations.
Closely monitors established leading indicators, measures daily/weekly outputs and plans activities to course-correct as needed (burndown plans, etc.) to ensure overall timeliness metrics are sustained.
Develop and manage the overall post market surveillance (PMS) activities to ensure compliance with FDA MDR and other evolving regulatory requirements.
Identify and communicate emerging trends in post market surveillance to drive product improvements.
Generate/update PMS system procedures as required (e.g., SQP, SOP, protocols, and reports).
Develop and maintain up-to-date knowledge on regulatory compliance, specifically FDA and EU requirements.
Work closely with other departments to set up quality files suitable for regulatory submissions.
All other duties as assigned.
RequirementsEducation:
Bachelors degree in engineering, science, or a related field.
Experience:
Minimum of 10 years of experience in quality assurance in the medical device industry.
Proven track record of successful management of quality teams and implementing quality management systems in accordance with applicable regulations and standards.
In-depth knowledge of FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), and other applicable regulations and standards.
Experience leading product development teams and ensuring that products meet or exceed quality standards and customer expectations.
Skills (Required):
Ability to handle multiple tasks while ensuring timely and accurate completion.
Strong analytical and problem-solving skills, including the ability to conduct risk assessments and develop risk management plans.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and regulatory agencies.
Physical:
Ability to sit or stand for extended periods of time.
Ability to lift and/or move up to 35 pounds.
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Job Category:Exempt
Department:Quality Assurance
Direct Report:Director of Quality
Location:92127
Travel Required:Up to 20%
Salary Range:$95,000 - $135,000
Position Type:Full-time/Onsite
Job DescriptionEssential Job Functions:
Position responsibilities include, but may not be limited to the following:
Develop and implement comprehensive quality assurance strategies, policies, and procedures that ensure compliance with applicable regulations and standards in the medical device industry.
Collaborate with cross-functional teams, including manufacturing, engineering, regulatory affairs, and operations, to identify and address quality-related issues and drive continuous improvement.
Responsible for quality system improvements for the company to gain certification to the ISO 13485 European standards along with compliance to MDR 2017/745/EU.
Develop quality metrics and monitoring to present on an ongoing basis and feed into Management Reviews.
Act as a quality representative and liaison with the contract manufacturing to ensure compliance with regulations.
Closely monitors established leading indicators, measures daily/weekly outputs and plans activities to course-correct as needed (burndown plans, etc.) to ensure overall timeliness metrics are sustained.
Develop and manage the overall post market surveillance (PMS) activities to ensure compliance with FDA MDR and other evolving regulatory requirements.
Identify and communicate emerging trends in post market surveillance to drive product improvements.
Generate/update PMS system procedures as required (e.g., SQP, SOP, protocols, and reports).
Develop and maintain up-to-date knowledge on regulatory compliance, specifically FDA and EU requirements.
Work closely with other departments to set up quality files suitable for regulatory submissions.
All other duties as assigned.
RequirementsEducation:
Bachelors degree in engineering, science, or a related field.
Experience:
Minimum of 10 years of experience in quality assurance in the medical device industry.
Proven track record of successful management of quality teams and implementing quality management systems in accordance with applicable regulations and standards.
In-depth knowledge of FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), and other applicable regulations and standards.
Experience leading product development teams and ensuring that products meet or exceed quality standards and customer expectations.
Skills (Required):
Ability to handle multiple tasks while ensuring timely and accurate completion.
Strong analytical and problem-solving skills, including the ability to conduct risk assessments and develop risk management plans.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and regulatory agencies.
Physical:
Ability to sit or stand for extended periods of time.
Ability to lift and/or move up to 35 pounds.
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