Quality Engineer I
Prolaio•Chicago, IL
•Hybrid
About The Position
The Quality Engineer I is responsible to support production activities including Quality Control activities for components and suppliers, in-process and finished goods inspection and release, and the transfer of products/processes from Design to Production. 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 4 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
- 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.
Nice To Haves
- CAPA experience is a plus
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.
- Work with Design and Production teams to ensure the successful transfer of products and processes from Design to Production.
- Support Complaint process by organizing investigations, if required, to ensure timely completion and documentation.
- Perform monitoring and measurement activities, reporting regularly to the Director, QMS, and to Management via Management Review processes.
Benefits
- Competitive salary + performance bonus + equity
- Medical, dental, and vision benefits with generous company contribution
- Company-provided life insurance
- 401(k) plan
- 13 paid company holidays + vacation + sick time
- Paid parental leave
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
