Process Quality Engineer

Philips • Bedford, MA

1d • Onsite

About The Position

The Process Quality Engineer is responsible for facilitating a state of high-quality performance, compliance, and critical oversight/performance monitoring of Philips manufacturing processes, driving compliance and continuous improvement throughout the manufacturing process. Your role: Facilitate operations performance monitoring, reporting, improvement and development, facilitate improvement programs in factory, and support analytical testing and Supplier Quality Engineering (SQE) and purchasing. Conducts 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. Handles nonconformance events/investigations in the factory, 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 Quality Notifications (QN) 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. Acts as an advisor to meet schedules and/or solve technical problems, develops and administers schedules and performance requirements, and may have budget responsibilities. Cultivates effective relationships, demonstrating full understanding of area of specialization, demonstrates good working relationships with suppliers, and previous experience of participation in several New Product Introductions (NPIs). 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. Discusses detailed, strategic quality metrics and reports with stakeholders, highlighting significant achievements, emerging trends, and actionable insights to drive advanced improvement initiatives and ensure regulatory compliance. Delivers specialized advanced training programs on cutting-edge quality standards, advanced methodologies, and best practices, fostering alignment across functions and advancing excellence in operational practices at an expert proficiency level. Manage 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. Evaluate equipment control processes, including calibration and maintenance, to ensure compliance with quality and regulatory requirements.

Requirements

• 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 and the ability to mentor less experienced engineers.
• 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, Reliability and Post Market Surveillance (PMS) insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle.
• 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 (Required), in Quality, Engineering or similar disciplines.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
• US work authorization is a precondition of employment.
• For this position, you must reside in or within commuting distance to Bedford, MA.

Nice To Haves

• ASQ-CQE, ISO Lead Auditor certifications-desired

Responsibilities

• Facilitate operations performance monitoring, reporting, improvement and development
• Facilitate improvement programs in factory
• Support analytical testing and Supplier Quality Engineering (SQE) and purchasing
• Conducts 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
• Handles nonconformance events/investigations in the factory
• 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 Quality Notifications (QN) 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
• Helps in completion of New Product Introduction (NPI) and product transfers in factory
• 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
• Discusses detailed, strategic quality metrics and reports with stakeholders, highlighting significant achievements, emerging trends, and actionable insights to drive advanced improvement initiatives and ensure regulatory compliance
• Delivers specialized advanced training programs on cutting-edge quality standards, advanced methodologies, and best practices, fostering alignment across functions and advancing excellence in operational practices at an expert proficiency level
• Manage 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
• Evaluate equipment control processes, including calibration and maintenance, to ensure compliance with quality and regulatory requirements

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees