Quality Engineer

Philadelphia, PA, USA
Regulatory
6239
Full Time
Competitive, great bonus and benefits
24-07-2020 12:17 PM

Company

Working for an incredible growing MedTech company with life-saving products in Medical Devices. This company have novel devices that have a massive impact on patients and they are set to experience continued explosive growth over the coming years. They are a stable company with good investment and are looking to add a crucial member to their Quality Organisation.

 

This role is a Quality Engineer position.

 

Job Role and Responsibilities:

  • Manage and Maintainance of the Quality Management System (QMS)
  • Assist in Internal audits on systems and documentation
  • Adhere to QMS requirements outlined in procedures and work instructions
  • Write, update and/or review SOPs and QA technical data forms and quality documents
  • Authors nonconformance reports and CAPAs
  • Review validation protocols for GMP compliance
  • Performs investigations of non-conformances, customer complaints and corrective actions
  • Prepares quality metrics and presents to management
  • Assists with contract manufacturer engineering change orders (ECO)
  • Ensures follow up and resolution of identified or assigned quality issues
  • Taking the lead as the Design Control Coordinator: works with product development engineering to ensure proper completion of required documentation for design control phases according to the design controls Standards of Practice (SOPs).
  • Audits suppliers, systems, and documents to assure quality assurance compliance with all internal procedures as well as regulatory guidelines.
  • Maintains and demonstrates an understanding of global standards, regulations, and regulatory bodies to include but not limited to ISO 13485:2016, 21 CFR part 820, 21 CFR part 812, MDSAP and MDR

 

Qualifications:

  • 2+ years experience in Quality Assurance in Medical Devices (e.g., ISO 13485:2016, 21 CFR Part 820 and MDSAP) in a Quality Engineering or Design Control position
  • Strong experience and understanding of Design Controls
  • Bachelor of Science in Engineering or Life Science Field
  • Working knowledge of standards and regulations as outlined in the QMS documentation and structure
  • ISO 13485:2016 auditor preferred

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