Quality Operations Manager
About The Position
The Operations Quality Manager will manage the Quality Operations team and coordinates, designs and executes activities for multiple Quality Operations projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements for Philips’ Image Guided Therapy Devices (IGTD). Your role: Responsible for implementing policy changes, ensuring product quality, managing manufacturing processes, coordinating product inspections, qualifying materials, overseeing supplier processes, executing recall procedures, producing quality assurance deliverables, and fostering collaboration across departments to achieve project goals and operational excellence. Manages/mentors the Quality Operations team, contributing to employee selection, performance management, career development, and overseeing operational processes. Implement quality processes and tools necessary to ensure product quality and enhance customer satisfaction, fostering a culture of excellence and continuous improvement within the organization. Manages the review and approval of finished products manufactured, coordinates all inspections and inquiries regarding the operation of manufacturing site to ensure compliance with company standards and manufacturing process specifications. Participates in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to manufacturing operations within Philips or at contracted suppliers. Drives quality investigations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from nonconformances. Supports internal /external audit programs, assists in preparation of audit responses and leads CAPA activity-CAPA board, reviews investigations, ensures appropriate CAPA actions, may own CAPA. Manages- calibration activities for instrumentation, measurement and test equipment, resource optimization, and incoming material and outgoing product acceptance activities, resource optimization, and compliance with regulations. Monitors operational key performance indicators (KPIs), Identifies, facilitates, and/or leads continuous improvement efforts and maintains Quality Metrics to support process improvement activities. Responsible for coordinating, facilitating and follow up on any Quality Leadership Team action items assigned.
Requirements
- Minimum of 5+ years’ experience in FDA regulated medical device environments, with a focus on Operations Quality (IQ/OQ/PQ), process/continuous improvement, CAPA activities and internal /external audit programs.
- Experience leading quality teams/projects
- Functional team management experience (desired), 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, cGMP, and GDP.
- Proven experience utilizing Quality KPI’s/Data Analysis to assess project 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
- Implementing policy changes
- Ensuring product quality
- Managing manufacturing processes
- Coordinating product inspections
- Qualifying materials
- Overseeing supplier processes
- Executing recall procedures
- Producing quality assurance deliverables
- Fostering collaboration across departments
- Managing/mentoring the Quality Operations team
- Contributing to employee selection, performance management, career development, and overseeing operational processes
- Implementing quality processes and tools
- Managing the review and approval of finished products manufactured
- Coordinating all inspections and inquiries regarding the operation of manufacturing site
- Participating in cross-functional teams as a Quality technical resource
- Providing quality oversight and support to manufacturing operations
- Driving quality investigations and reviewing corrective action plans
- Performing root cause analysis and product impact assessments
- Supporting internal/external audit programs
- Assisting in preparation of audit responses
- Leading CAPA activity-CAPA board
- Reviewing investigations
- Ensuring appropriate CAPA actions
- Managing calibration activities for instrumentation, measurement and test equipment
- Managing resource optimization
- Managing incoming material and outgoing product acceptance activities
- Monitoring operational key performance indicators (KPIs)
- Identifying, facilitating, and/or leading continuous improvement efforts
- Maintaining Quality Metrics to support process improvement activities
- Coordinating, facilitating and follow up on any Quality Leadership Team action items assigned
Benefits
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Manager
