The Quality Engineer - External Relationships will be responsible for managing quality aspects of relationships with suppliers and customers. Primary focus will be on Supplier Controls, Nonconformance Management, Change Control/Communication, and Managing Supplier/Customer audits. This position ensures that the solid execution of company programs remain consistent with the overall company values. The ideal candidate has a solid understanding of QA processes and can support the strategic and operational objectives of the business. The successful candidate will possess a high degree of professionalism, maturity and confidentiality.
Essential Job Functions:
Manage several core elements of the Quality Management System as it relates to suppliers and customers, including:
Supplier Management
Nonconformance Management
Change Control
Complaint Investigation
Audits
Develop and update procedures, specifications, and standards for internal products and processes to support continuous improvement initiatives within applicable QMS elements
Maintain tracking/trending files for assigned QMS elements and run status reports as needed
Provide support during External Audits (FDA, Notified Body, etc.)
Perform periodic Internal Audits, as required.
Foster a culture of collaboration, partnership, teamwork, customer service, and a drive for change and continuous improvement.
Assume a lead role in identified elements of the QMS and take ownership and responsibility over those elements
Propose and drive improvements to the Quality Management System to streamline business processes
Assist with various special ad hoc projects and other duties as assigned
Competencies:
Integrity - We act in all ways with respect and transparency, ethically and honestly, with everyone. Our work represents who we are, as we create products we can proudly recommend to our loved ones.
Collaboration - We are only successful together, operating as one diverse and inclusive team with each other and our customers.
Determination - We are passionate, dedicated, and tenacious about our goals.
Creativity - We are passionate trailblazers, relentless in our pursuit of continuous improvement.
Moved by Urgency - Patients depend on us delivering our products with enthusiasm, efficiency, and diligence. Our obligation and privilege is to drive urgency on patients' behalf
Education, Experience and Certification:
Bachelor's Degree in engineering or biological sciences
Minimum of 5 years' Medical Device Quality Assurance experience
Ability to follow written and oral instructions with minimal supervision
Ability to work in a team environment and build relationships outside the organization (suppliers, customers, regulatory agencies, etc.)
Highly familiar with cGMP, Good Documentation Practices, auditing, and quality management systems
Very effective verbal and written communication skills