119 applicants
AirLife · 2 days ago
Senior Quality Engineer-Risk and Post Market
Grand Rapids, MI
Full-time
Remote
Senior Level
7+ years exp
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Responsibilities
Lead and participate in activities to determine compliance with applicable regulatory requirements and company standards.
Leads the Risk Management Quality System process in conformance with US FDA Quality System Regulations and ISO 14971.
Conduct risk assessments, including the identification of hazards, estimation of risks, and evaluation of risk mitigation strategies.
Collaboration with cross-functional teams to develop and implement risk mitigation plans.
Mentors and provides direction to development and sustaining teams in risk management activities.
Fosters and maintains organizational compliance to the Risk Management Quality System process including on-going training and education
Maintain deep understanding of the Risk Management process, including linkages and interactions of all impacted functional areas
Prepare Post Market Surveillance Plan and Reports to schedule to support EU MDR and other country specific requirements for post market surveillance.
Stay up-to-date with industry trends, regulatory changes, and emerging risks, and proactively recommend improvements to the Risk Management and Post Market Surveillance process.
Performs other related duties and projects as business needs require at direction of management.
Qualification
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Required
Thorough understanding of policies, regulations, standards, and best practices of risk management.
Thorough understanding of policies, regulations, standards, and best practices of post market surveillance.
Strong decision-making abilities.
Demonstrated technical writing skills.
Excellent organizational skills, attention to detail, and strong analytical skills
Effective communication skills, with an ability to work and influence cross-functionally
7+ years of experience in Quality, Regulatory, Engineering or related field in a medical device environment.
Proven understanding of quality management systems, regulations, and standards (e.g. FDA QSR, ISO 13485, EU MDR)
A bachelor’s degree in Engineering, Science, or related fields.
Preferred
Experience with software risk management preferred.
Experience in continuous improvement is preferred.
ASQ certification is preferred.
Experience in quality systems and management is a strong plus.
Approximately 15% including international travel.
Company
AirLife
AirLife is a healthcare company that specializes in anesthesia and respiratory care products.
5,001-10,000 employees
Funding
Current Stage
Late StageLeadership Team
Hendrik Struik
Chairman and CEO at AirLife
Caitlin Anderson
Chief Administrative Officer, General Counsel, & Corporate Secretary
Company data provided by crunchbase
