Quality Engineer

Our client designs and manufactures custom medical devices that save lives and restore patient health and vital function in the hands of skilled doctors. They are excited about this important work and bring vital energy to their customer partnerships!

Our client builds complex catheters that provide a pathway to the heart, to the brain, and to the peripheral vasculature. Industry experts in advanced catheters who partner with customers to guide them on every step of the product development path, from start to finish.

They are 100% focused on complex catheters and sheaths and are an approved supplier for many Tier 1 OEMs. With their engineers deep technical knowledge, well-developed proprietary processes, dedication to following through our commitments, and extensive in-house capabilities, they are the best-kept secret in the medical device industry!

Are you a Quality Engineer with a desire, drive, and grit to lead in a growing contract manufacturer?

If so, we d love to learn more about you.

POSITION SUMMARY

The Quality Engineer is responsible for assisting in the creation and maintenance of the Quality Systems necessary for compliance with applicable regulations and customer needs. This includes ensuring that these Quality Systems are appropriate for VitalPath needs, that they are followed, and are defended to auditors. The Quality Engineer is also an internal resource for continuous improvement and statistics-based decision making.

DUTIES & ESSENTIAL JOB FUNCTIONS

• The Quality Engineer will be responsible for the definition, implementation and continuous improvement of quality related practices and procedures.
• Ensure compliance with applicable laws and regulations; FDA CFR 820 and ISO 13485.
• Assist in the administration and implementation of the Quality Management System, including new product development (NPD) and operations roles as follows:

NPD:

• Work with customers and project engineers to develop and refine specifications based on VitalPath capability and customer needs.
• Develop measurement systems for new projects, creating programs on automated inspection equipment and performing Gage R&R as needed.
• Develop and oversee execution of validation protocols and summarize results in reports.
• Create inspection plans.
• Drive projects to production handoff.

Operations:

• Maintain quality systems.
• Investigate and disposition nonconformance's.
• Create, drive, and close CAPAs.
• Resolve customer complaints.
• Manage customer change notifications and associated validation efforts.
• Assist in or drive continuous improvement projects.
• Review and approve changes to controlled documents.
• Assist during customer and regulatory audits.
• Advise internal team members, operations, and quality staff on quality topics.
• Drive revision and approval of inspection procedures.

QUALIFICATIONS

• 3 years experience in medical device manufacturing, in a quality role.
• Knowledge of ISO 13485 Medical Device Quality Management System.
• Excellent communication and influencing skills.
• Ability to focus efforts on prevention measures, follow through on commitments and hold team members accountable to results.
• Preferred: Experience with quality engineering tools and principles for process development & improvement and root cause analysis including Ishikawa (Fishbone) diagrams, 5 whys, A3, DMAIC