Senior Quality Operations Engineer

Job Title

Senior Quality Operations Engineer

Job Description

The Senior Quality Operations Engineer is responsible for supporting a state of high-quality performance, compliance, and oversight/performance monitoring of Philips manufacturing processes, driving compliance and continuous improvement throughout the manufacturing process.

Your role:

• Support operations performance monitoring, reporting, improvement and development, facilitate quality improvement programs in factories.
• Handles nonconformance events/investigations in the factory, leverages Process Failure Mode and Effects Analysis (PFMEA) to assess risk, guides material review board activities for non-conformance disposition management, leads analysis of defects for determining dispositions of non-conformances, drives management of Non-Conformances (NC) and facilitates implementation of effective Corrective and Preventive Actions (CAPA) actions
• Facilitates timely quality engineering and quality assurance tasks, ensures manufacturing quality systems are maintained, handles single or complex process validation and process improvement activities, and helps in completion of New Product Introduction (NPI) and product transfers in factory.
• Possesses working knowledge Quality Engineering and Continuous Improvement techniques, follows processes and operational policies in selecting methods for obtaining solutions, and frequently interacts with supervisors and functional peer groups to gain cooperation of others
• Leads validation protocols, facilitates production builds to support validation activities, analyzes data for reports, process improvement initiatives, and validation activities.
• Utilizes advanced statistical analysis methods to interpret complex data trends, resolve a wide range of moderate complexity requests, and provide strategic insights for continuous enhancement of quality standards and process efficiency.
• Ability to interpret and/or create detailed, quality metrics and reports with stakeholders, highlighting significant achievements, emerging trends, and actionable insights to drive advanced improvement initiatives and ensure regulatory compliance.
• Delivers training programs on quality standards, advanced methodologies, and best practices, fostering alignment across functions and advancing excellence in operational practices at an high proficiency level.
• Experience managing incoming inspection programs, equipment control processes (including calibration and maintenance), environmental monitoring programs (viable and non-viable) including data analysis and trending, and support sterilization, endotoxin process analysis to ensure compliance with regulatory and quality requirements.

You're the right fit if:

• You have a minimum of 5+ years’ experience in FDA regulated (ISO 13485) medical device quality operations/manufacturing environments, with a focus on quality operations, audit support, process validation/improvement, CAPA, non-conformance, PFMEA’s and Change/Risk Management (ISO 14971).
• You have proven experience leading cross-functional teams
• You have detailed experience/knowledge in CAPA processes non-conformances, including problem identification, root cause analysis, implementation of solutions to prevent recurrence and drive continuous improvement.
• You’re experienced in utilizing Quality) insights/data analytics to lead continuous improvement.
• You’re able to build/cultivate relationships with supervisors, functional peer groups, internal/external stakeholders, suppliers etc.
• Previous experience in environmental control programs and sterilization validation.
• You have a minimum of a Bachelor’s Degree in Engineering. ASQ-CQE, ISO Lead Auditor 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 a part. 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 ON-SITE 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 Bedford, MA is $102,480 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.

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