Overview
Quality Engineer/ QA Specialist Jobs in Philadelphia, PA at EPM Scientific
Title: Quality Engineer/ QA Specialist
Company: EPM Scientific
Location: Philadelphia, PA
About the Role
Quality Assurance Engineer
Location: New Britain, PA (Onsite)
Department: Quality Assurance & Quality Engineering
Reports To: Quality Leadership Team
Travel: Periodic supplier audits and cross-site collaboration
A global medical device manufacturer is seeking a Quality Assurance Engineer to support product and process quality across the full product lifecycle. This role is ideal for a detail-oriented, collaborative professional with a strong foundation in quality engineering, supplier oversight, and continuous improvement within regulated environments.
Key Responsibilities
Product & Process Quality
Independently review protocols, reports, and records to ensure compliance with internal procedures and regulatory standards.
Support product and process changes by ensuring robust documentation and risk-based decision-making.
Drive improvements in inspection methods, acceptance criteria, and measurement systems across the supply chain.
Non-Conformance & CAPA Management
Lead investigations into non-conforming materials and products, coordinating root cause analysis and corrective/preventive actions.
Ensure timely implementation and verification of corrective actions.
Maintain accurate documentation and provide trend analysis and reporting on quality issues.
Supplier Quality Oversight
Evaluate and qualify suppliers to ensure they meet quality and regulatory requirements.
Conduct supplier audits and maintain ongoing relationships through periodic visits and performance reviews.
Collaborate with suppliers to drive quality improvements and enhance process maturity.
Cross-Functional Collaboration
Partner with R&D, Operations, Procurement, and Regulatory Affairs to ensure quality is embedded throughout the product lifecycle.
Provide quality engineering support during product development, manufacturing, and post-market activities.
Qualifications
Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
Minimum 3 years of experience in quality engineering within a regulated industry (medical devices preferred).
Strong understanding of ISO 13485, ISO 9001, and applicable regulatory standards.
Experience with supplier quality management, audits, and CAPA processes.
Familiarity with mechanical, plastic, or electrical components and their manufacturing methods.
Proficiency in inspection and measurement techniques and statistical quality control.
Fluent in English (written and spoken); additional languages a plus.
Key Competencies
Self-motivated and capable of working independently in a global, cross-functional environment.
Strong analytical and problem-solving skills with a continuous improvement mindset.
Effective communicator with the ability to influence and collaborate across departments and cultures.
High level of integrity and commitment to quality and compliance.
No Relocation or Visa Sponsorship available
