Medical Device Quality Systems Associate I

Quality Engineer / Quality Associate I

PECA Labs is a Pittsburgh-based medical device company within the cardiovascular space that manufactures both vascular graft and valve products. The Quality Engineer / Quality Associate I position is a team-oriented position that will be part of the Quality Department and will work closely in conjunction with the Regulatory, Manufacturing, and Research and Development teams.

This position will include the following responsibilities :

• Assist with maintaining and updating the company's ISO 13485, EU MDR, and FDA-Compliant Quality Management System (QMS)
• Contribute to the creation, approval, and distribution of quality documents
• Provide support in ensuring the proper control of documents (e.g., ensure that document revisions are aligned, obsolete documents are removed, etc.)
• Participate in CAPA investigations and Root Cause identification
• Aid in the maintenance of training records and competency assessments
• Support the preparation of Regulatory submissions
• Take part in risk management activities
• Assist with gathering and reporting quality metrics
• Help ensure that quality procedures and documents are accessible to relevant personnel
• Provide support in the manufacturing of PECA Labs medical devices
• Help with Supplier management activities
• Foster collaborative, efficient and effective working relations with compliance authorities while participating in internal and external audits and inspections.

The following are preferred :

Experience and educational requirements :