Quality Operations Manager-Ultrasound

Philips•Reedsville, PA

27d•$120,000 - $190,000•Hybrid

About The Position

The Quality Operations Manager will be responsible for Quality team management, oversight of quality operations, driving critical quality/continuous improvement initiatives and ensuring site compliance for our Reedsville Ultrasound Transducer manufacturing site.

Requirements

Minimum of 7+ years’ experience in FDA regulated medical device manufacturing environments, with a focus on Operations/Process Quality (IQ/OQ/PQ), investigating/ supervising nonconformance events, CAPA activities, internal /external audit programs and process validation and continuous improvement.
Proven experience in functional management of quality teams, including budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc.
Strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR, GMP, and GDP.
Proven experience utilizing Quality KPI’s/Data Analysis to assess project/team performance and identify process and continuous improvement opportunities.
Able to effectively communicate, influence and build relationships with cross-functional team members, internal/external stakeholders at all levels, suppliers, and able to manage/facilitate audits and inspections with the FDA, competent authorities, Regulatory Agencies and Notified Body.
Minimum of a Bachelor’s degree in Quality, Engineering or a related Scientific discipline (required).

Nice To Haves

ASQ certifications (desired).

Responsibilities

Manages the Corrective and Preventive Actions (CAPA) process rigorously, investigating nonconformances, determining root causes, and implementing robust corrective and preventive actions, while monitoring CAPA effectiveness and overseeing the 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, report on project status of new products or transfers to factory and ensures validation activities and employee capabilities to support validation of process controls and completeness of New Product Introduction (NPI) or product transfers into factory to quality norms.
Drives strategic initiatives to elevate supplier quality standards, collaborating closely with cross-functional teams in Research & Development (R&D), manufacturing, and regulatory affairs to address process gaps and uphold superior quality benchmarks.
Possesses complete knowledge of products/services, often leads a cooperative effort among project team members, and frequently interacts with subordinates, supervisors, customers, and functional peer groups on matters between functional areas.
Drives resolution of quality non-conformities with Philips internal suppliers and drives process validation as local factory-level QMS process owner to ensure adherence to quality standards and regulatory requirements.
Manages talent across the team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.
Leads critical quality engineering and assurance tasks, ensuring the maintenance of manufacturing quality systems, ensuring risk management, and driving significant process improvement initiatives to facilitate New Product Introduction (NPI) completion and product transfers.
Manages issues necessitating an in-depth understanding of organizational objectives through the analysis of situations or data and implements strategic policies when determining methods, techniques, and evaluation criteria to achieve desired outcomes.