Sr Quality Manufacturing Engineer

Philips • Murrysville, PA

99d • Remote

About The Position

In this role you are responsible for achieving a state of high quality performance, compliance and sustainability in product inspection and the factories while pursuing continuous quality improvement through the application of Quality Engineering practices. Your role includes product ship holds and communications, performing regulatory quality control supportive activities, defining and/or translating the product quality inspection policy and strategy within a domain into technical solutions, determining the product quality inspection approach within the project and executing those product quality inspection activities, managing non-conformance events including CAPA management when required, and resolving quality non-conformities with Philips internal suppliers. You will also be involved in receiving inspection, WIP inspection, and FGD release, supporting SQE/SQA/Purchasing.

Requirements

• Bachelor's degree required.
• 5+ years of experience in a medical device or regulated industry (preferred).
• Direct inspection engineering sustaining experience.
• Direct working relationship with suppliers.
• Knowledge of quality systems, tools, and methodologies including Critical to Quality, FMEA, Root Cause Analysis, Pareto, 8-D, 5 Why, and Audit training.
• Basic understanding of CAPA and global medical device regulations such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
• Ability to perform minimum physical, cognitive, and environmental job requirements with or without accommodation.

Nice To Haves

• Experience with auditing suppliers.

Responsibilities

• Achieve high quality performance and compliance in product inspection.
• Pursue continuous quality improvement through Quality Engineering practices.
• Perform regulatory quality control supportive activities.
• Define and translate product quality inspection policy and strategy into technical solutions.
• Determine and execute product quality inspection activities within projects.
• Manage non-conformance events including CAPA management.
• Resolve quality non-conformities with internal suppliers.
• Support receiving inspection, WIP inspection, and FGD release.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees