Senior Quality Operations Engineer

Philips•Bedford, MA

1d•Onsite

About The Position

The Senior Quality Operations Engineer supports high-quality performance, compliance, and oversight of Philips manufacturing processes, driving compliance and continuous improvement throughout manufacturing. The role supports operations performance monitoring, reporting, and improvement; facilitates factory quality improvement programs; manages nonconformance investigations and dispositions; and drives effective corrective and preventive actions. It also supports quality engineering and assurance activities, manufacturing quality systems, process validation and improvement, new product introductions, and product transfers. The position leads validation protocols and production builds for validation, analyzes data for reporting and improvement, and applies advanced statistical methods to interpret complex trends and resolve moderately complex quality issues. The engineer creates and interprets quality metrics and reports with stakeholders, delivers training on quality standards and methods, and supports incoming inspection, equipment control, environmental monitoring, sterilization, and endotoxin process analysis. This is an on-site role in Bedford, Massachusetts. Travel may be required up to 10%. Candidates must reside in or within commuting distance of Bedford, MA, and must already have U.S. work authorization; sponsorship and relocation benefits are not provided.

Requirements

Minimum 5 years of experience in FDA-regulated (ISO 13485) medical device quality operations or manufacturing environments.
Experience focused on quality operations, audit support, process validation and improvement, CAPA, nonconformance, PFMEAs, and change/risk management under ISO 14971.
Proven experience leading cross-functional teams.
Detailed knowledge and experience in CAPA and nonconformance processes, including problem identification, root cause analysis, solutions to prevent recurrence, and continuous improvement.
Experience using quality insights and data analytics to lead continuous improvement.
Ability to build and cultivate relationships with supervisors, functional peer groups, internal and external stakeholders, and suppliers.
Bachelor’s degree in Engineering or higher.
Must be able to successfully perform the position’s minimum physical, cognitive, and environmental job requirements with or without accommodation.
U.S. work authorization is required; the company will not consider candidates who require work-visa sponsorship now or in the future.
Must reside in or within commuting distance of Bedford, MA.

Nice To Haves

Experience with environmental control programs and sterilization validation.
ASQ-CQE certification.
ISO Lead Auditor certification.

Responsibilities

Support operations performance monitoring, reporting, improvement, and development, and facilitate quality improvement programs in factories.
Handle factory nonconformance events and investigations; use PFMEA to assess risk and guide material review board activities and nonconformance dispositions.
Lead defect analysis to determine nonconformance dispositions, manage nonconformances, and facilitate effective CAPA implementation.
Perform quality engineering and assurance tasks; maintain manufacturing quality systems; handle process validation and improvement activities; and support NPI and product transfers.
Lead validation protocols, facilitate production builds for validation, and analyze data for reports, process improvement initiatives, and validation activities.
Apply advanced statistical analysis to interpret complex data trends, resolve moderately complex requests, and provide insights for quality and process-efficiency improvements.
Create and interpret quality metrics and reports with stakeholders, highlighting achievements, trends, and actionable insights to advance improvement and regulatory compliance.
Deliver training on quality standards, advanced methodologies, and best practices across functions.
Manage incoming inspection programs, equipment controls including calibration and maintenance, and environmental monitoring programs, including data analysis and trending.
Support sterilization and endotoxin process analysis to help ensure regulatory and quality compliance.
Lead cross-functional teams and cultivate relationships with supervisors, peer groups, internal and external stakeholders, and suppliers.