Description

JOB SUMMARY:

This position administrates regulatory compliance activities related to New World Medical’s (NWM) Supplier Management. Responsible for establishing the system for managing suppliers which includes establishing systems for the approval, monitoring and validation of the suppliers. This role is the technical liaison between our suppliers and R&D, Sustaining Engineering, and Operations. This position focuses on strategic thinking and influencing others within the organization. Shapes the technical direction of complex quality projects, influencing key stakeholders and driving alignment on quality strategies. Tackles complex quality challenges, providing innovative solutions that minimize risk and ensure patient safety and product efficacy.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

Leads projects with limited scope for Supplier Quality on NPD projects. Takes a leading role in key meetings, clearly articulating project goals, technical challenges, and progress using their influence to reorient project directions and technical decisions within the team and in broader organizational contexts.
Lead PPAP process with suppliers to establish robust validated processes including measurement methodologies (Gage R&R). Balances risks, considers long-term impact(s), and makes informed choices.
Works with suppliers and New World Medical’s R&D, Sustaining and Production Department to establish, maintain, and assess associated risks of their controlled manufacturing processes.
Builds and maintains relationships with suppliers to establish and verify/audit control methods suitable to the nature of the parts they supply and ensure clear communication of New World requirements to all levels of manufacturing.
Works with suppliers to establish a structured approach for consistency and adherence to quality procedures and requirements.
Schedules, manages, and conducts audits of New World Medical existing and potential new suppliers to assess compliance to all applicable Standards, Regulations, and New World Medical Requirements.
Identifies compliance risks to current standards/regulations and assists in the planning and execution of Quality System improvements to mitigate those risks.
Drives continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams including NWM and suppliers.
Follow-up with non-conformances during in-process inspection, pre-shipment inspection, quality complaints from internal customers, product returns and safety recalls. Identify/drive root cause analysis, corrective action and preventive action implementation.

Requirements

KNOWLEDGE, SKILLS AND ABILITIES:

Strong organizational, time management and project management skills with attention to detail.
Must have effective communication skills.
Able to work autonomously and independently.
Must be a team player and have a strong work ethic.
Demonstrated ability to lead, acknowledge, develop, communicate & implement strategies for developing new supplier, including qualification.

EDUCATION AND EXPERIENCE:

7+ years of experience with Bachelor’s degree or 10+ years of experience.
Direct experience with supplier producing product and parts in a regulatory environment (i.e. GMPs, ISO13485, 21 CFR Part 820, etc.) preferred.
Must have knowledge of Quality Engineering discipline, including statistics.
Strong working knowledge of DMAIC/Six Sigma problem solving process. Belt certified is a plus.
Competent in Process Audit, CAPA, PPAP, Equipment Validation and Gage R&R.
Certified Auditor Qualification or equivalent is required.

PHYSICAL REQUIREMENTS:

Must be able to remain in a stationary position at least 50% of the time.
Occasionally move about inside the office and travel to and from office buildings to access file cabinets, employee offices, office machinery, etc. This may include, but is not limited to, bending and walking.
Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
Ability to listen and speak with employees and suppliers. Must be able to exchange accurate information in these situations.
View and type on computer screens for long periods of time.
The expected travel for this position is approximately 20%-30%.

This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.