Senior Quality / Design Assurance Engineer

Senior Quality / Design Assurance Engineer

Senior Quality / Design Assurance Engineer

We are working with an exciting medical device company dedicated to creating patient-centric solutions in the field of palliative care. Due to company growth, our client is now hiring a Senior Quality / Design Assurance Engineer.   The primary technological platform under development, involves a catheter-based device designed to address fluid accumulation in the body associated with advanced-stage cancers. Responsibilities include but are not limited to the following:

• Apply engineering expertise in various areas, such as quality systems, supplier controls, design assurance, test method development and validation, design controls, and regulatory affairs.
• Manage and enhance quality systems within the organization to ensure compliance with medical device regulations.
• Implement and oversee controls and processes related to suppliers to ensure the quality of incoming components and materials.
• Contribute to the design assurance process, ensuring that product designs meet quality standards and regulatory requirements.
• Develop and validate testing methods to assess the performance and quality of medical devices.
• Collaborate with regulatory affairs teams to navigate and ensure compliance with FDA and European regulatory requirements.
• Stay updated on and ensure adherence to medical device regulations, including GMP, QSR, and ISO quality requirements.
• Work under medical device design controls, demonstrating proven knowledge of design verification/validation and design/process FMEAs.
• Utilize excellent problem-solving, decision-making, and root cause analysis skills, with a focus on the DMAIC methodology.
• Apply knowledge and practice risk management methodologies as per ISO 14971.
• Maintain accurate documentation and reporting related to quality and design assurance activities.
• Collaborate closely with the Contact Manufacturer and other stakeholders in the development and market launch of products.
• Demonstrate strong initiative, follow-through, and effective project leadership in executing responsibilities, overcoming obstacles, and managing multiple priorities.
• Other duties as required

Requirements

• Minimum Bachelor’s degree in science, engineering, or a related field.
• At least five (5) years of experience in a similar role within medical device quality systems, with a preference for experience as a Quality Systems or Supplier Quality Engineer.
• Expertise in medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations), and ISO quality requirements.
• Strong knowledge of device design controls, design verification/validation and design/process FMEAs.
• Strong collaborative and leadership skills.
• Desired skills include excellent problem-solving, decision-making, and root cause analysis (DMAIC).
• Knowledge and demonstrated practice of risk management methodologies as per ISO 14971.
• Advantageous experience in Ethylene Oxide sterilization, biocompatibility, and transportation testing.
• Proficiency with MS Office suite is required.
• Prerequisite experience working in both FDA and European regulatory environments.
• Desired experience in class II and above medical devices.

Very competitive salary on offer for this position, including stock options and flexible working hours. This role requires you to be onsite. Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies. #J-18808-Ljbffr