Quality Assurance Specialist, Quality Systems

Job overview

The Quality Assurance Specialist, Quality Systems role is onsite in Philipsburg, PA; compensation is not specified. The role supports Drucker Diagnostics, which designs and manufactures benchtop centrifuges used to prepare samples for diagnostic testing and regenerative therapies. The specialist strengthens quality systems and helps ensure products and processes meet applicable regulatory and quality requirements. Through investigations, audits, risk management, validation, and improvement work, the role supports the safety and reliability of medical devices used by laboratories and healthcare providers.

What you'll do

• Own designated Quality Management System processes
• maintain and improve the QMS in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable requirements
• support internal, customer, regulatory, and certification audits
• review product, process, and QMS changes
• conduct investigations and root-cause analysis
• lead nonconformance resolution and corrective and preventive actions
• perform risk assessments
• support quality plans, process validation, and quality control
• analyze quality metrics and trends
• lead or support improvement initiatives and promote compliance.

What we're looking for

Skills & competencies

quality assurance

quality systems

medical devices

iso 13485

fda 21 cfr part 820

capa

risk management

audits

philipsburg pa

drucker diagnostics

manufacturing quality

continuous improvement

Work arrangement

• Weekend coverage required

Benefits & perks

• 401(k) with company match
• medical, dental, and vision insurance
• HSA or FSA with company match
• employer-paid basic life insurance with AD&D
• up to 10 paid holidays plus birthday
• paid time off.

Why this role

The posting’s narrative identifies the role as a Quality Systems Lead and describes QMS process ownership, CAPA, risk management, audits, and process validation. Occasional travel may be required for supplier activities, audits, training, or meetings.

About the employer

Drucker Diagnostics is hiring for this role. Industry: Electromedical and Electrotherapeutic Apparatus Manufacturing. Sector: 33.