Quality Operations Manager-Ultrasound

Quality Operations Manager – Ultrasound (Reedsville, PA)

The Quality Operations Manager will oversee a Quality team and manage quality operations, driving critical quality and continuous improvement initiatives while ensuring site compliance. This role requires deep expertise in FDA‑regulated medical device manufacturing, CAPA, audits, process validation, and supplier quality.

• Manages the Corrective and Preventive Actions (CAPA) process rigorously, investigating nonconformances, determining root causes, implementing corrective actions, monitoring CAPA effectiveness, and overseeing management of Non‑Conformances (NC) and Quality Notifications (QN).
• Plans the assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities.
• Provides oversight for testing robustness of product transfer validations in the factory, reports on project status of new products or transfers, and ensures validation activities and employee capabilities support validation of process controls and completion of New Product Introduction (NPI) or product transfers to factory quality norms.
• Drives strategic initiatives to elevate supplier quality standards, collaborating closely with cross‑functional teams in R&D, manufacturing, and regulatory affairs to address process gaps and uphold superior quality benchmarks.
• Drives resolution of quality non‑conformities with Philips internal suppliers and serves as local factory‑level QMS process owner to ensure adherence to quality standards and regulatory requirements.
• Manages talent across the team, including employee selection, performance management, compensation management, career development, and effective operational management.
• Leads critical quality engineering and assurance tasks, ensuring maintenance of manufacturing quality systems, risk management, and driving significant process improvement initiatives to facilitate NPI completion and product transfers.
• Handles issues requiring in‑depth understanding of organizational objectives through analysis of situations or data and implements strategic policies to achieve desired outcomes.

• Minimum 7+ years’ experience in FDA‑regulated medical device manufacturing environments, focusing on Operations/Process Quality (IQ/OQ/PQ), CAPA, audits, and continuous improvement.
• Proven functional management of quality teams, including budgeting, workforce planning, performance management, employee engagement, succession planning, coaching, and training.
• Strong understanding of Medical Device regulations/standards: ISO 13485/14971, 21
  
  CFR (803, 806, 820), MDD/EU MDR, GMP, and GDP.
• Experience utilizing Quality KPIs/Data Analysis to assess team performance and identify process improvement opportunities.
• Excellent communication, influence, and relationship‑building skills with cross‑functional teams, stakeholders, suppliers, and auditors.
• Minimum Bachelor’s degree in Quality, Engineering, or a related scientific discipline (required). ASQ certifications desired.

• Must reside in or within commuting distance to Reedsville, PA.
• Up to 10% travel may be required.

• Pay range: $120,000 – $190,000 (based on experience, skill set, and internal equity).
• Competitive total rewards program: generous PTO, 401(k) (up to 7% match), HSA with company contribution, stock purchase plan, education reimbursement.

Philips is an Equal Employment and Opportunity Employer, including Disability/Vets, and maintains a drug‑free workplace. We comply with all federal, state, and local laws regarding equal opportunity. We provide reasonable accommodations for individuals protected by the Rehabilitation Act, the Vietnam Veterans' Readjustment Act, and the Americans with Disabilities Act. Know your rights.