Quality Operations Manager

Philips; Colorado; On-site; USD 98,000 - 164,000; Full time

Benefits offered by this job

PTO (paid time off)

401k match (up to 7%)

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Quality Operations Manager to lead the Quality Operations team and drive compliance with regulatory requirements for Image Guided Therapy Devices. The role coordinates multiple projects, implements policy changes, and fosters continuous improvement across manufacturing processes.

You will mentor the team, manage CAPA and audits, monitor KPIs, and ensure product quality from inspection to release.

Qualifications

• Minimum 5+ years in FDA-regulated medical devices, Operations Quality.
• Experience leading quality teams/projects and budgeting.
• Knowledge of ISO 13485/14971, 21 CFR 803/806/820, EU MDR, cGMP, GDP.
• Proficient in Quality KPI and data analysis.
• Ability to communicate with cross-functional stakeholders and manage audits.

Responsibilities

• Implement policy changes to ensure product quality and compliant manufacturing.
• Mentor and manage the Quality Operations team; organize performance development.
• Develop and apply quality processes and tools to improve customer satisfaction.
• Coordinate inspections and ensure finished product release per standards.
• Lead CAPA activities and root cause analysis for investigations.
• Support internal/external audits and prepare audit responses.
• Manage calibration of instrumentation and measurement equipment.
• Monitor KPIs and drive continuous improvement.
• Coordinate and follow up on Quality Leadership Team actions.

Skills

Quality leadership

Cross-functional collaboration

Regulatory compliance

Data analysis

Audits

CAPA management

Root cause analysis

KPI monitoring

Communication

Team mentoring

Education

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

ASQ certifications

Tools

Quality management systems

Job description

Job Title

Quality Operations Manager

Job Description

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 aQuality technical resourceresponsible 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.

You’re the right fit if:

• You have 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.
• You have experience leading quality teams/projects, functional team management experience (desired), including budgeting, workforce planning, Performance Management, Employee Engagement/ Retention, Succession Planning, coaching, training, etc.
• You have strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR, cGMP, and GDP.
• You have proven experience utilizing Quality KPI’s/Data Analysis to assess project performance and identify process and continuous improvement opportunities.
• You’re 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.
• You have a minimum of a Bachelor’s degree in Quality, Engineering or a related Scientific discipline (required). ASQ certifications (desired).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together:

We believe that we are better together than we are apart. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time (5 days per week) presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Onsite role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won’t stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

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

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

Additional Information:

• This role may require travel up to 10%.
• US work authorization is a precondition of employment. The company WILL NOT consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• Company relocation benefits WILL NOT be provided for this position. For this position, you must reside in or within commuting distance to Fremont, CA.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.