Quality Engineer/ QA Specialist
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
FAQs
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