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Senior Quality Engineer-Risk and Post Market- GR, MI or remote

1 month ago

Grand Rapids, United States SunMed Full time
Location: within 50 miles of Grand Rapids- Hybrid

Outside of this range- remote.

COMPANY DESCRIPTION

At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work. Join us

POSITION SUMMARY

The major purpose of this position is to lead the Risk Management Quality System process and lead necessary on-going activities to support Post Market Surveillance for assigned product categories. The risk management activities include oversite of the Risk Management process for compliance with US FDA Quality System Regulations and ISO 14971. The post market surveillance activities include applicable monitoring and reporting to meet applicable regulatory requirements (i.e. FDA, EU MDR, Health Canada) and include but are not limited to: identifying strategic focus areas for continuous improvements, product/process enhancements, implementing proactive quality activities, monitoring and measuring the overall performance and ensuring compliance to quality systems and regulatory requirements.

POSITION QUALIFICATIONS

The specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.

Knowledge: Acquired through education, certifications, training, experience.
  • 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
Level of Experience:
  • 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)
  • Experience with software risk management preferred.
  • Experience in continuous improvement is preferred.
  • Experience in quality systems and management is a strong plus.
Level of Education:
  • A bachelor’s degree in Engineering, Science, or related fields.
  • ASQ certification is preferred.
Travel:

Approximately 15% including international travel.

ESSENTIAL DUTIES AND RESPONSIBLITIES

The core tasks, duties, and responsibilities that must be performed on the job.
  • 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.
OTHER RESPONSIBLITIES
  • Focus on achieving our Company mission.
  • Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
  • Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
  • Use time efficiently; perform job accurately and thoroughly.
  • Contribute to building and maintaining a positive team environment.
  • Assure all policies and guidelines are implemented and followed.

QUALITY POLICY

At AirLife, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

DEIA STATEMENT

At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.