Quality Specialist

Prolaio • Chicago, IL

7d • Hybrid

About The Position

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.

Requirements

• 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 knolwedge of regulatory inspections/audits

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• Competitive salary
• performance bonus
• equity
• Medical, dental, and vision plans with multiple options and strong company contributions.
• HSA
• FSA
• commuter benefits
• a $1,200 annual Lifestyle Spending Account to support wellness, commuting, family needs, and more.
• Generous paid time off
• sick leave
• company holidays.
• Paid parental leave
• caregiver leave
• support for growing families.
• Company-paid life insurance
• short- and long-term disability coverage.
• 401(k) plan
• Easy access to telehealth
• optional supplemental coverage for life’s unexpected moments.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level