Quality & Regulatory Leader — Medical Devices

Drucker Diagnostics; Philipsburg (Centre County); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Mission-driven work

Professional development opportunities

Collaborative team environment

Job summary

A healthcare technology company in Philipsburg is looking for a Quality Manager to oversee quality management systems and ensure compliance with regulatory standards. The ideal candidate will have a Bachelor's Degree and at least 5 years in a regulated environment like pharmaceuticals or medical devices. You will lead compliance initiatives, manage quality control activities, and enhance product reliability, playing a crucial role in safeguarding patient health. Join us to make a significant impact in healthcare.

Qualifications

• Minimum of 5 years of experience in an FDA-regulated environment.
• Experience with Quality System documentation required.
• Strong organizational and communication skills essential.

Responsibilities

• Lead Quality, Regulatory, and Compliance Strategy.
• Manage day-to-day Quality Control and Assurance activities.
• Track, analyze, and report Quality KPIs.

Skills

Leadership

Quality Management Systems

ISO 13485 Knowledge

Regulatory Affairs

Problem-solving

Customer Focus

Education

Bachelor’s Degree in Engineering, Chemistry, Biology, or related discipline

Tools

MS Office Suite

Document Management Systems

Adobe Acrobat

ERP Systems

Job description

A healthcare technology company in Philipsburg is looking for a Quality Manager to oversee quality management systems and ensure compliance with regulatory standards. The ideal candidate will have a Bachelor's Degree and at least 5 years in a regulated environment like pharmaceuticals or medical devices. You will lead compliance initiatives, manage quality control activities, and enhance product reliability, playing a crucial role in safeguarding patient health. Join us to make a significant impact in healthcare.