Quality Engineer/ QA Specialist


New Britain, PA
Permanent
Negotiable
Quality
PR/550843_1751049144
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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