Quality Operations Leader for Medical Devices & NPI

Philips; Reedsville (PA); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Generous PTO

401k matching

Stock purchase plan

Education reimbursement

HSA with company contribution

Job summary

Philips is seeking a Quality Operations Manager-Ultrasound in Reedsville, PA. You will manage the quality team, oversee CAPA, NCs and QN, and drive PFMEA impacts and design transfers to ensure product quality for ultrasound transducer manufacturing.

You will lead supplier quality programs, ensure QMS compliance, and drive continuous improvement across R&D, manufacturing, and regulatory affairs while maintaining strong stakeholder relationships and end-to-end product quality ownership.

Qualifications

• 7+ years in FDA-regulated medical device manufacturing environments, Operations/Process Quality (IQ/OQ/PQ)
• Experience managing quality teams including budgeting, workforce planning, performance management
• Strong knowledge of ISO 13485/14971, 21 CFR 803/806/820, MDD/EU MDR, GMP, GDP
• Experience using Quality KPI’s/Data Analysis to assess performance and drive improvements
• Ability to communicate, influence and manage audits/inspections with FDA and regulatory bodies
• ASQ certifications desired but not required, Bachelor’s degree mandatory
• Must meet physical, cognitive and environmental job requirements

Responsibilities

• Manage CAPAs, investigate nonconformances, determine root causes, implement corrective actions
• Oversee NPIs and product transfers to maintain quality standards
• Lead supplier quality initiatives and cross-functional collaboration with R&D, manufacturing, regulatory
• Ensure QMS, risk management and process validation support NPI and transfers
• Manage talent, performance, compensation, and succession planning
• Lead quality engineering tasks and maintain manufacturing quality systems
• Drive process improvements and regulatory compliance across site

Skills

CAPA management

Root cause analysis

Process validation

Regulatory compliance

Quality metrics

Cross-functional leadership

Audits & inspections

Education

Bachelor's degree in Quality, Engineering or related Scientific discipline

Job description

Philips is seeking a Quality Operations Manager-Ultrasound in Reedsville, PA. You will manage the quality team, oversee CAPA, NCs and QN, and drive PFMEA impacts and design transfers to ensure product quality for ultrasound transducer manufacturing.

You will lead supplier quality programs, ensure QMS compliance, and drive continuous improvement across R&D, manufacturing, and regulatory affairs while maintaining strong stakeholder relationships and end-to-end product quality ownership.