PURPOSE/SUMMARY (Brief overview of why job exists, general purpose for position)

The Manager, Quality Assurance is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for corporate OEM Supply base. This is a key technical and leadership position, affecting product quality for “Distributed by” and “Manufactured for” products.    

ESSENTIAL DUTIES AND RESPONSIBILITIES (List of 8 – 10 key tasks required of the job which occupy greater than 5% of the incumbents time)

• Manage (Improve/sustain) supplier quality performance for all OEM suppliers via established Quality Plan implementation.
• Manage the OEM supplier process change process
• Manage OEM supplier audit program and overall supplier approval/rating program through robust qualification processes.
• Manage supplier compliance to corporate and regulatory requirements through supplier monitoring process.
• Manage and implement supplier/engineering changes, New Product Introductions, and transfers by developing positive relationships and working closely with Global Sourcing Leaders
• Interface with Supply Chain, Suppliers, Service, and Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically Incoming Rejects, Failures, and Factory defects.
• Work  with OEM product support teams Supply Chain, R & D, and regulatory on final product quality issues and supplier initiatives
• Work directly with OEM suppliers under the control of the Company’s Quality/Logistics.
• Support implementation of initiatives such as “Dock to Stock”, “Drop Shipments”, “Min/Max Programs” and “Kanban”.
• Assure Corrective and Preventive Action plans are developed and executed at assigned OEM suppliers in compliance with the CAPA process.
• And/or other duties as may be assigned.

SUPERVISOR RESPONSIBILITIES (IF ANY) – Optional section (List of subordinate jobs for which this job has direct hire/discipline/budget responsibility)

• Manages 2-3 employees in the OEM Quality Assurance and Quality Control areas.

MINIMUM QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND/OR EXPERIENCE

Education:

• Bachelors Degree in an engineering or technical discipline (or non-technical degree with 3 years of experience in manufacturing, engineering or quality assurance experience).

Experience:

• Minimum 5 years experience in medical device related to quality assurance and/or regulatory assurance.
• Proficiency with Microsoft Excel spreadsheet development and analysis.
• Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
• Willing to travel domestically and/or internationally up to 50% of time.
• Ability to travel on a short notice

·         Must have unrestricted legal authorization to work in the United States (US positions only).

CERTIFICATES, LICENSES, REGISTRATIONS

• Desirable Certifications:

• ASQ Certified Quality Engineer, Auditor, or equivalent