Quality Engineer

Philips • Lockbourne, OH

12d • $92,000 - $146,000 • Hybrid

About The Position

The Quality Engineer is responsible for qualifying/ensuring Philips’ Hospital Patient Monitoring (HPM) parts, components and materials are safe, compliant and reliable, ensuring patient safety and customer satisfaction. Your role: Executes timely quality engineering/assurance processes, ensures maintenance and documentation of quality assurance systems, and reviews/approves quality documentation/records, with responsibility for their generation when necessary. Executes: the organization's comprehensive quality assurance and compliance policy, cultivates internal quality awareness, introduces and enforces necessary processes and tools to ensure product excellence and customer satisfaction, standardizes quality systems across sites and sectors, and institutes an efficient Management Review process. Contributes to improvement initiatives and implements change within the domain, tackles diverse challenges creatively, and exhibits sound judgment in selecting methods and techniques to effectively resolve issues. Reviews and approves nonconforming records related to warehouse material, executes delivery hold, and supports nonconformance management processes, including root cause analysis, and corrective and preventive actions (CAPA), all conducted within specified timelines. Analyzes quality data for reports, validation processes, and process improvement initiatives, troubleshoots departmental issues, escalates issues to the direct manager as needed, and may generate departmental metrics and reports to management. Helps to verify quality assurance departmental metrics, monitors and analyze daily management board data, and generates insights from departmental metrics to report to management for informed decision making. Ensures the qualification and maintenance of sub-processes within supplier networks, conducts supplier quality audits, applies company excellence practices to identify and resolve major supplier quality issues, and supports continuous improvement initiatives in supplier performance and product quality. Conducts routine quality inspections and audits across manufacturing processes, materials, and finished products to identify deviations and non-conformities. Participates in initiatives aimed at establishing uniform approaches and methodologies to promote uniformity within the supply base and facilitates cohesion and efficiency across operations.

Requirements

• Minimum of 3+ years’ experience in FDA regulated Medical Device manufacturing/warehousing quality environments (ISO 13485), with a focus on parts qualification, quality audits/inspections, nonconformance management, control plans, QMS compliance/standardization, and continuous/process improvement
• Proven experience in Risk Management (ISO 14971), root cause analysis and CAPA
• Proven experience in data analysis- monitoring and analyze daily management board data and generate insights from departmental metrics to report out to management
• Minimum of a Bachelor's Degree in an Engineering or quality discipline
• 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.
• Must reside in or within commuting distance to Lockbourne, OH.

Nice To Haves

• Six Sigma/DfX (DfQ/DfR) knowledge and/or certifications desired

Responsibilities

• Executes timely quality engineering/assurance processes
• Ensures maintenance and documentation of quality assurance systems
• Reviews/approves quality documentation/records, with responsibility for their generation when necessary
• Executes the organization's comprehensive quality assurance and compliance policy
• Cultivates internal quality awareness
• Introduces and enforces necessary processes and tools to ensure product excellence and customer satisfaction
• Standardizes quality systems across sites and sectors
• Institutes an efficient Management Review process
• Contributes to improvement initiatives and implements change within the domain
• Tackles diverse challenges creatively
• Exhibits sound judgment in selecting methods and techniques to effectively resolve issues
• Reviews and approves nonconforming records related to warehouse material
• Executes delivery hold
• Supports nonconformance management processes, including root cause analysis, and corrective and preventive actions (CAPA), all conducted within specified timelines
• Analyzes quality data for reports, validation processes, and process improvement initiatives
• Troubleshoots departmental issues
• Escalates issues to the direct manager as needed
• May generate departmental metrics and reports to management
• Helps to verify quality assurance departmental metrics
• Monitors and analyze daily management board data
• Generates insights from departmental metrics to report to management for informed decision making
• Ensures the qualification and maintenance of sub-processes within supplier networks
• Conducts supplier quality audits
• Applies company excellence practices to identify and resolve major supplier quality issues
• Supports continuous improvement initiatives in supplier performance and product quality
• Conducts routine quality inspections and audits across manufacturing processes, materials, and finished products to identify deviations and non-conformities
• Participates in initiatives aimed at establishing uniform approaches and methodologies to promote uniformity within the supply base and facilitates cohesion and efficiency across operations

Benefits

• Generous PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• Stock purchase plan
• Education reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level