Quality Engineer - Medical Device Industry

A new product line is entering development, and my client needs a Quality Engineer to guide its design activities and ensure compliance throughout the process. This position will also take the lead in creating and organizing documentation for the company's quality systems and related programs. The employer is a specialized manufacturer that builds electro-mechanical solutions exclusively for the medical device industry Client Details

You'll be joining a company whose electro-mechanical expertise powers an extensive range of medical technologies used across nearly 50 countries. As they continue to expand, the team is preparing to roll out an entirely new product line-one that will rely heavily on your day-to-day involvement. Certified under ISO 13485, the organization is growing quickly and offers the chance to contribute to work that directly improves patient outcomes around the world.

Description

• Develop and maintain quality systems and programs to ensure compliance with ISO, FDA, MDSAP, and other regulatory requirements.
• Oversee key areas of management responsibility, including:
• Auditing
• Corrective and preventive actions
• Training
• Process control
• Validation
• Customer complaint handling
• Design controls
• Equipment calibration
• Purchasing controls
• Document control

Design Control & Product Development

• Collaborate as a team member on product and process design improvements.
• Execute verification and testing protocols for product launches and design changes.
• Maintain Design History Files (DHFs) and Device Master Records (DMRs).

Supplier Quality Management

• Analyze data and trends related to complaints, supplier quality, and nonconforming materials.
• Investigate customer complaints and ensure timely resolution.
• Monitor corrective actions for implementation and effectiveness.
• Conduct supplier audits to ensure compliance and quality standards.

Risk Management

• Lead risk assessments, including Failure Modes and Effects Analysis (FMEA), and implement appropriate risk control measures.
• Maintain Risk Management Files for device families.

Profile

• Bachelor's Degree (Engineering-related preferred)
• 5+ years of manufacturing experience within quality
• Understanding of ISO 9001 and ISO 13485
• Experience with electro-mechanical processes
• Design control experience (design reviews, verifications, validations, DFMEAs, etc.)
• Understanding of ISO 14971 and UL 60601 is preferred
• CQE certification is preferred
• Six Sigma belt is preferred
• Sponsorship is not provided

Job Offer

• Base salary between $90,000 - $120,000
• Health, dental, vision
• 401(k) matching
• 3 weeks PTO
• Opportunity for a hybrid work schedule after training period

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.