Supplier Quality Manager

Company Description

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

Job Description

POSITION SUMMARY:

The Supplier Quality Manager (SQM) reports directly to the Director, Operations Quality and will be responsible for management and execution of assigned supplier quality projects in order to meet quality assurance and engineering objectives. The Supplier Quality Manager is responsible for daily operations in the supplier quality department and completes duties such as liaising with suppliers, performing supplier quality audits, managing supplier corrective actions, and ranking suppliers for development.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Lead supplier development strategy, designing the metrics for the function and supplier performance
• Works jointly with Operations and Development on new supplier selection and development
• Maintains the Approved Supplier List and Supplier Audit Schedule
• Manages and communicates status of supplier quality project budgets, timelines and resources
• Supports concurrent engineering efforts by participating in design development and sustaining projects, representing supplier quality to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirements
• Manages the new product qualification process to ensure suppliers are capable of delivering to the required quality standards
• Interfaces with supplier quality representatives concerning issues with quality assurance and assures that effective corrective action is implemented by managing the root cause analysis and corrective actions process of supplier quality issues
• Works closely with Development, Product Advancement Engineering and suppliers to achieve a seamless transfer to manufacturing process and cost-effective design for manufacturability process.
• Review and evaluate supplier quality data to identify process improvement opportunities within the supply chain
• Build and manage the Supplier Quality Team
• Leads supplier onsite and desktop audits
• Participates in quality system audits (FDA, ISO, Internal, etc.)
• Creates and updates quality system procedures working on cross-functional teams to align best practices, procedures, and applicable regulations (FDA, ISO, etc.)
• Develop, execute and analyze supplier quality-reporting measures

Qualifications

KNOWLEDGE, SKILLS, AND ABILITIES:

• Must be able to use MS Office computer software including Word, Excel, PowerPoint, and Project
• Must be a team player; must work collaboratively and productively with other business partners to meet company goals and objectives
• Must be willing to travel ~20-30% of the time for vendor visits, audits, process troubleshooting, etc.
• Must demonstrate a strong sense of ownership and accountability
• Must demonstrate strong interpersonal and verbal/written communication skills
• Must be extremely detail oriented and able to demonstrate strong organizational and communication skills
• Ability to interact with remote manufacturing and quality resources to insure product meets company standards for manufacturability, reliability and cost-effectiveness
• Expertise in inspection techniques, critical measuring, and measurement variation
• Ability and willingness to be a productive member of cross-functional teams to assist in the creation of quality documents for assigned projects, as required by applicable medical device standards and internal procedures
• Ability to work cross-functionally to support rapid growth and continuous improvement.

MINIMUM REQUIREMENTS:

• Education and Experience: Bachelor's degree in Engineering, Science, Technology or a related discipline with 7-10 years of progressive medical device engineering experience (Manufacturing, Development or Quality Engineering) within an FDA compliant, CFR, Title 21, Part 820, environment

Additional Information

WORK ENVIRONMENT: 

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, fili