Role Summary/Purpose
A Senior Site Quality Leader is responsible for ensuring quality compliance of a large facility, while driving process effectiveness and efficiency. The Site Quality Leader represents the company with external agencies and champions the implementation of the QMS and the evolution of the quality culture for the site.
Essential Responsibilities:
Directing the Site Quality Management System, fully integrated into the company Global Quality Management System, including cross-functional and site-specific processes. The role is responsible for facility compliance covering voluntary, regulatory and company quality requirements and will champion quality initiatives at all levels of the organization.
- Maintaining and improving all aspects of Site Quality Planning.
- Overseeing all Quality-related communications and training requirements for all site employees.
- Establishing positive relationships with outside agencies.
- Ensuring site audit readiness and hosting Quality System audits and inspections.
- Overseeing the Corrective Action / Preventive Action activities and Complaint Handling programs, and in some cases, Quality Engineering.
- Report on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews.
- Driving the definition of site quality objectives, metrics, reporting and operating mechanisms.
- Participating in selected global initiatives to share best practices and leverage quality synergies.
- Supporting local R&D programs and quality issue resolution.
- Acting as Management Representative for Quality at the Site.
Qualifications/Requirements
Bachelor's degree in Engineering, Medical Device Technology or Scientific Field (or High School diploma/GED and a minimum of 10 years work experience and understanding of product development, manufacturing, quality control and servicing in a medical equipment environment). Minimum 5 years professional experience and understanding of product development, manufacturing, quality control and servicing in the medical equipment or pharmaceutical industry. Minimum 3 years supervisory/ management experience, including hiring, training, coaching and performance management activities. Hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements. Proven track record in performing external and internal audits. Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations. Effective report, business correspondence and procedure writing skills. Good problem identification, multivariable analysis and creative resolution aptitude. Proven process development and project management skills. Strong computer skills. Ability to communicate using English
Desired Characteristics
Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions. Experience in a global, matrixed organization structure. Professional certification as a Lead Auditor. Six Sigma training and/or certification Team player with a global mindset. Strong Change Acceleration skills. Experience in building a Quality System from ground up. Front line operational responsibility in Engineering, Manufacturing or Sourcing.
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