ICAD, Inc
Manager, Quality Assurance
ICAD, Inc, Nashua, New Hampshire, us, 03062
Manager of Quality Assurance
POSITION DESCRIPTION:
The Quality Manager for Software as a Medical Device (SaMD) will be responsible for ensuring the quality and compliance of software products used as medical devices both domestically and internationally. This role involves developing, implementing, and maintaining quality systems and processes that meet regulatory requirements and industry standards. The Quality Manager will work closely with cross-functional teams at iCAD to ensure the highest standards of product quality and patient safety.
RESPONSIBILITIES:
The key responsibilities of this position include, but are not limited to, the following:
Develop, implement, and maintain the Quality Management System (QMS) for SaMD in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
Ensure software development processes comply with IEC 62304 and other relevant standards.
Conduct risk management activities in accordance with ISO 14971.
Oversee software manufacturing activities to ensure compliance and product quality.
Manage the documentation of quality assurance activities, including SOPs, work instructions, and quality records.
Coordinate internal and external audits and inspections, ensuring readiness and compliance.
Lead CAPA (Corrective and Preventive Action) processes to address product and process non-conformances.
Collaborate with R&D, Regulatory Affairs, and other departments to ensure quality is built into the product lifecycle from design to post-market surveillance.
Oversee the Quality Training Program ensuring that employees are trained to the current SOPs, work instructions, and safety requirements.
Serve as management representative.
Provide training and support to staff on quality processes and regulatory requirements.
Stay current with industry best practices, standards, and regulatory changes impacting SaMD.
REQUIREMENTS / EXPERIENCE:
Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field. Advanced degree preferred.
Minimum of 5 years of experience in quality assurance or regulatory affairs within the medical device industry, with a focus on software.
In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, IEC 62304, and ISO 14971.
Experience working with the EU Medical Device Regulation (MDR), Health Canada Regulations, and other international standards.
Experience with software development lifecycle (SDLC) methodologies and software quality assurance practices.
Proven experience working with Agile methodologies in a small nimble environment, with a deep understanding of agile principles and practices.
Strong understanding of risk management principles and practices.
Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
Detail-oriented with strong analytical and problem-solving skills.
Certification in quality management (e.g., CQE, CQA) is a plus.
EDUCATION / TRAINING:
BS Degree, or equivalent relevant experience.
TRAINING and/or CERTIFICATIONS:
ASQ Certified Quality Engineer or Certified Quality Manager is a plus.
Certified RAPS Professional is a plus.
LOCATION:
Remote (US)
iCAD is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, layoff or termination. iCAD does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by federal, state or local law, ordinance or regulation.
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POSITION DESCRIPTION:
The Quality Manager for Software as a Medical Device (SaMD) will be responsible for ensuring the quality and compliance of software products used as medical devices both domestically and internationally. This role involves developing, implementing, and maintaining quality systems and processes that meet regulatory requirements and industry standards. The Quality Manager will work closely with cross-functional teams at iCAD to ensure the highest standards of product quality and patient safety.
RESPONSIBILITIES:
The key responsibilities of this position include, but are not limited to, the following:
Develop, implement, and maintain the Quality Management System (QMS) for SaMD in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
Ensure software development processes comply with IEC 62304 and other relevant standards.
Conduct risk management activities in accordance with ISO 14971.
Oversee software manufacturing activities to ensure compliance and product quality.
Manage the documentation of quality assurance activities, including SOPs, work instructions, and quality records.
Coordinate internal and external audits and inspections, ensuring readiness and compliance.
Lead CAPA (Corrective and Preventive Action) processes to address product and process non-conformances.
Collaborate with R&D, Regulatory Affairs, and other departments to ensure quality is built into the product lifecycle from design to post-market surveillance.
Oversee the Quality Training Program ensuring that employees are trained to the current SOPs, work instructions, and safety requirements.
Serve as management representative.
Provide training and support to staff on quality processes and regulatory requirements.
Stay current with industry best practices, standards, and regulatory changes impacting SaMD.
REQUIREMENTS / EXPERIENCE:
Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field. Advanced degree preferred.
Minimum of 5 years of experience in quality assurance or regulatory affairs within the medical device industry, with a focus on software.
In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, IEC 62304, and ISO 14971.
Experience working with the EU Medical Device Regulation (MDR), Health Canada Regulations, and other international standards.
Experience with software development lifecycle (SDLC) methodologies and software quality assurance practices.
Proven experience working with Agile methodologies in a small nimble environment, with a deep understanding of agile principles and practices.
Strong understanding of risk management principles and practices.
Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
Detail-oriented with strong analytical and problem-solving skills.
Certification in quality management (e.g., CQE, CQA) is a plus.
EDUCATION / TRAINING:
BS Degree, or equivalent relevant experience.
TRAINING and/or CERTIFICATIONS:
ASQ Certified Quality Engineer or Certified Quality Manager is a plus.
Certified RAPS Professional is a plus.
LOCATION:
Remote (US)
iCAD is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, layoff or termination. iCAD does not unlawfully discriminate on the basis of race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by federal, state or local law, ordinance or regulation.
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