• Bachelor's Degree in Engineering field

Required Skills:

• 4 + years of experience in industry required
• Experience supporting EU-MDR programs
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• Firm understanding of Med Device concepts.
• Familiarity with ISO 13485 and EU Regulations, GDP, GMP concept.
• Excellent communication skills and attention to detail.
• Good understanding of engineering and quality concepts / theories.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.
• Be willing to work as part of a multi-site team.
• Have knowledge of Risk Based and statistical concepts is.
• Problem solving and analytical skills.
• Be able to build strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach.
• Ability to be the voice of Quality when dealing cross functionally.
• Excellent English (both oral and written).
• Up to 10% travel may be required

MUST HAVES

• Great problem solving and critical thinking skills (4+)
• Able to independently use engineering rationale make decisions (4+)
• Knowledge/Experience EU-MDR Programs/Initiatives (2+)

Job Summary:

• Provide quality engineering support for manufacturing operations and cross-functional business functions.
• Lead and support EU Medical Device Regulation (EU MDR) initiatives for an assigned product portfolio.
• Develop and implement quality methods for process control, process improvement, testing, and inspection activities.
• Ensure products comply with applicable regulatory requirements and quality standards while meeting design and performance expectations.
• Support First Article Inspection (FAI) strategy development, execution, documentation, and approvals.
• Participate in Production Part Approval Process (PPAP) activities for new and existing products.
• Perform engineering change control reviews and change impact assessments.
• Support equipment, manufacturing process, and product validations (IQ/OQ/PQ).
• Review, update, and maintain Standard Operating Procedures (SOPs), risk management documentation, and quality records.
• Apply Quality Management System (QMS) principles to drive compliance with

ISO 13485, EU

• Investigate quality issues, identify root causes, and implement corrective and preventive actions.
• Analyze quality data to identify trends and recommend continuous improvement initiatives.
• Collaborate with Engineering, Manufacturing, Regulatory Affairs, Supply Chain, and Operations to ensure product quality and regulatory compliance.
• Serve as the voice of Quality by providing technical guidance and ensuring quality standards are maintained across cross-functional teams.
• Build strong stakeholder relationships through effective communication, collaboration, and customer-focused support.
• Utilize sound engineering judgment, analytical thinking, and problem-solving skills to resolve complex quality issues.
• Manage multiple priorities independently while contributing as an individual technical contributor within a multi-site organization.
• Support internal and external audits, inspections, and regulatory compliance activities as needed.
• Maintain accurate documentation and reports using Microsoft Office applications and applicable quality systems.
• Only those lawfully authorized to work in the designated country associated with the position will be considered.
• Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.