Quality Manager Jobs

Responsibilities:

• Managing and Measuring Work

o Ensures compliance to the quality management systems in all activities performed within Creganna Medical
o Leads and supports audits from external regulatory agencies (FDA, BSI, JPAL) and customers and to lead preparation activities in advance of such audits.
o Ensures all customer queries and concerns are professionally addressed in a timely manner and escalates critical issues as appropriate, while delivering on an extraordinary customer experience.
o Participates in new product introductions to ensure quality is built into all products early in their life cycle.
o Oversees the design development of Design History Files (DHF) for new products and ensures regulatory compliance.
o Leads and demonstrates expertise in the areas of QSR and ISO standards within one’s own group, constantly promoting awareness of industry best practices and making appropriate decisions.
o Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
o Utilizing the best in class problem solving tools, drives robust and effective corrective and preventive actions through the CAPA system.
o Participates and leads in an active role the execution of the site’s TEOA Program.

• Building Effective Teams & Motivating Others

o Demonstrates commitment to the Quality Policy (patient safety and product quality) through the daily execution of sound quality practices and the maintenance of an effective quality system.
o Ability to work with a cross-functional team to develop and deliver on the site strategic targets and objectives.
o Mentors and trains staff to perform effectively in their work and ensures the training is documented.
o Engages and manages a high-performance quality engineering team. Creates a strong team working environment with focus on customer needs, compliance, product quality, and risk mitigation.
o Develop talent by creating training and development plans with associate input into their career objectives

• Strategy, Execution, Talent

o Work with site leadership team to develop strategic plans for obtaining annual objectives and goals.
o Measures and monitors key process indicators to proactively evaluate the execution of meeting and/or exceeding the strategic plans developed.
o Develops and retain the associates that contribute to the success of obtaining the goals and objectives of the organization.