Quality Engineer

Philips•Murrysville, PA

2d•Hybrid

About The Position

The Quality Engineer is responsible for resolving complex quality issues, utilizing post-market analytics for continuous improvement, and preparing for quality audits to maintain adherence to internal and external standards, working under general supervision. For example, this role includes preparing technical and standards-based information to respond to regulatory inquiries.

Requirements

Proficiency in Root Cause Analysis, Risk Management, Correction and Removals, Auditing along with a general understanding of ISO 9001, ISO 13485, FDA CRF 21 part 820 and Good Manufacturing Practices (GMP).
Proficient with Microsoft Office applications.
Bachelor's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent/ Vocational Education.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

Nice To Haves

1+ years of experience in medical device or a regulated industry, preferred.
Experience with eQMS (Trackwise, ARIS) and ERP (SAP) software desired.

Responsibilities

Addresses and resolves quality engineering issues of medium to high complexity, applying established processes and policies to provide efficient resolutions.
Prepares for and support quality audits and inspections, ensuring all necessary documentation and processes are in place and compliant with internal and external standards.
Reviews and assesses the detailed quality engineering documents, including quality plans for hardware, software, and system design, ensuring accuracy and regulatory compliance.
Proposes and initiates multiple quality improvement projects, integrating quality, reliability, and Post Market Surveillance (PMS) plans at all stages of the product lifecycle.