Quality Operations Manager

About the role

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).

Responsibilities

• Implement 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.
• Manage/mentor 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.
• Manage the review and approval of finished products manufactured, coordinate all inspections and inquiries regarding the operation of manufacturing site to ensure compliance with company standards and manufacturing process specifications.
• Participate 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.
• Drive 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.
• Support internal /external audit programs, assist in preparation of audit responses and lead CAPA activity - CAPA board, reviews investigations, ensures appropriate CAPA actions, may own CAPA.
• Manage calibration activities for instrumentation, measurement and test equipment, resource optimization, and incoming material and outgoing product acceptance activities, resource optimization, and compliance with regulations.
• Maintain Quality Metrics to support process improvement activities, and coordinate, facilitate and follow up on any Quality Leadership Team action items assigned.

Requirements

• A 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.
• Effective communication, influence and building relationships with cross-functional team members, internal/external stakeholders at all levels, suppliers, and ability to manage/facilitate audits and inspections with the FDA, competent authorities, Regulatory Agencies and Notified Body.
• A minimum of a Bachelor’s degree in Quality, Engineering or a related Scientific discipline (required).
• ASQ certifications (desired).

Qualifications

• Ability to perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Skills

• 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.
• Effective communication, influence and building relationships with cross-functional team members, internal/external stakeholders at all levels, suppliers, and ability to manage/facilitate audits and inspections with the FDA, competent authorities, Regulatory Agencies and Notified Body.

Benefits

Details about our benefits can be found here.

Pay

The pay range for this position in Fremont, CA is $103,00 to $163,968.

Schedule

This role may require travel up to 10%.

Additional Information

• This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.
• Interested candidates are encouraged to apply as soon as possible to ensure consideration.
• Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.