Prolaio
Healthcare
QualitySpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Specialist at Prolaio. Skills: Quality Management, Regulatory compliance. Support production activities. Perform Quality Control activities”
Industry & Context.
Critical thinker; Creative problem solver
What They're Looking For.
Must Have
2 years of work experience in Medical Device or Pharmaceutical production environments, Experience with ISO 13485, Experience with CFR Part 820, Working knowledge of regulatory inspections/audits
Nice to Have
Bachelor's degree
What You'll Do.
Support production activities
Perform Quality Control activities
Inspect in-process goods
Inspect finished goods
Process Complaint records
Ensure component specifications are complete
Ensure component specifications are accurate
Ensure suppliers are qualified
Document supplier qualification
Perform quality inspections of finished goods
Perform quality inspections of device history records
Release goods if accepted
Support environmental monitoring activities
Support Complaint process
Organize investigations for complaints
Ensure timely completion of complaint investigations
Ensure documentation of complaint investigations
Comply with Quality Management System expectations
How You'll Work.
Team & Collaboration
Regulatory, Quality, and Clinical Development Operations Team
Full Job Description
Who Are We? Prolaio believes that continuous learning and collaboration can make a significant difference in how heart care is administered. We are creating smarter ways to address heart disease and heart risks by uniting patients, care teams, and researchers on a secure, technology-enabled platform that drives clinical innovation and offers a path towards better patient outcomes. This is precision cardiology, and we know it’s within reach. What Will You Do? The Overview The Quality Specialist is responsible for supporting production activities, including Quality Control activities for components and suppliers, and in-process and finished goods inspection. The Quality Specialist is also responsible for processing Complaint records according to established procedures. This role reports to the Director, Quality Management Systems working on the Regulatory, Quality, and Clinical Development Operations Team. This is a hybrid role based in our Chicago office. The Specifics Ensure specifications for components are complete and accurate prior to acceptance activities. Ensure suppliers for components and services that may impact product quality are formally qualified and documented as such. Perform quality inspections of finished goods and device history records, and release goods, if accepted. Support environmental monitoring activities. Support Complaint process by organizing investigations, if required, to ensure timely completion and documentation. Comply with the expectations of the Quality Management System (QMS), including Biosketch forms, job descriptions, training, etc. Why Prolaio? Impactful Work: You will join in the fight against heart failure (HF) and hypertrophic cardiomyopathy (HCM) with the goal of extending and saving the lives of our patients while also being at the forefront of changing the healthcare industry through technology. Innovative Environment: You will be part of an organization doing something that’s never been done before. Professional Growth:
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