Quality Specialist

Prolaio; Chicago (IL); On-site; USD 54,000 - 66,000; Full time

Benefits offered by this job

Competitive salary

Medical, dental, and vision plans

Generous paid time off

Paid parental leave

401(k) plan

Job summary

Dormont Manufacturing Co, located in Chicago, Illinois, seeks a Quality Specialist responsible for quality control activities of production components. This hybrid role requires ensuring proper specifications and compliance with regulatory standards.

The ideal candidate will have a Bachelor's degree or 2 years of experience in the Medical Device or Pharmaceutical industry, with knowledge of ISO 13485.

Competitive salary starting at $60,000, along with comprehensive health coverage and flexible benefits, make this an excellent opportunity.

Qualifications

• Bachelor’s degree preferred, or at least 2 years of work experience in Medical Device or Pharmaceutical production environments.
• Experience with ISO 13485 and CFR Part 820.
• Working knowledge of regulatory inspections/audits.

Responsibilities

• Ensure specifications for components are complete and accurate prior to acceptance activities.
• Perform quality inspections of finished goods and release goods if accepted.
• Support environmental monitoring activities.

Skills

Quality Control

Regulatory Compliance

ISO 13485

Critical Thinking

Problem Solving

Education

Bachelor’s degree in relevant field

2 years of experience in Medical Device or Pharmaceutical production

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 QualityControl 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: You will join a growing team and have a substantial impact on our daily and future operations with the opportunity to continuously learn and grow.
• Collaborative Team: You will be part of a team of collaborative, curious, and committed individuals focused on the collective good, inclusiveness, scientific excellence, and advancing digital health for cardiology.

Who You Are?

Experience and Education

• Bachelor’s degree preferred, or at least 2 years of work experience in Medical Device or Pharmaceutical production environments.
• Experience with ISO 13485 and CFR Part 820
• Working knowledge of regulatory inspections/audits

Additional Qualifications

• Passionate about what you do and excited about contributing your skills to enable better healthcare through technology.
• Humble, kind, and keen to receive and act on feedback, excited to help your teammates, and celebrates the success of your team.
• Can work independently with minimal supervision and proactively identify and mitigate future challenges.
• Are a critical thinker and creative problem solver who can collaborate effectively with individuals internally and externally.
• Eager to learn and grow and is not afraid of challenging and complex work.

Company Benefits

• Meaningful Compensation: Competitive salary, performance bonus, and equity so you can share in what we build.
• Great Health Coverage: Medical, dental, and vision plans with multiple options and strong company contributions.
• Flexible Spending Perks: HSA, FSA, commuter benefits, and a $1,200 annual Lifestyle Spending Account to support wellness, commuting, family needs, and more.
• Time to Recharge: Generous paid time off, sick leave, and company holidays.
• Family-First Benefits: Paid parental leave, caregiver leave, and support for growing families.
• Security & Peace of Mind: Company-paid life insurance and short- and long-term disability coverage.
• Plan for the Future: 401(k) plan to help you build long-term financial security.
• Care When You Need It: Easy access to telehealth and optional supplemental coverage for life’s unexpected moments.

Starting Salary is at $60,000.00 (Exact Compensation may vary based on skills, experience, and location)