Responsibilities
Include but are not limited to the following:
- Key contact with customers for quality, service, and delivery issues and ensures the entire job focus to be timely, effective, and responsive to the customer
- Serve as a representative during audits by customers
- Support the customer by providing technical assistance through information sharing, research, and special projects
- Responsible for writing, revising, reviewing, and/or approving Product Specifications, Delivery Specifications, and other customer and/or product specific specifications and ensure these are upheld to the customer’s expectations
- Work with Applications and Development to review documentation to ensure new product lines meet CSP Quality System and customer requirements
- Responsible for writing and/or approving Run Time Plans, test protocols, and summary reports for existing and developmental products related to existing and potential customers
- Responsible for writing new procedures, revising, reviewing, and/or approving for new and current processes
- Evaluate data from production and research/experiments and put into presentable format for internal and external use
- Lead and coordinate special projects to support and promote quality and productivity at CSP.
- Manage the Quality Engineering Department through training and coaching/mentoring of procedures, deviations, and continuous improvement/DMAIC projects
- Support the development of the Quality Engineering Department through training, networking, and work experiences that help them achieve their career goals and interests
- Direct and assist internal activities as a management representative when necessary
- Responsible for developing and driving internal metrics within the Quality Engineering Department
- Ascribes to and supports Aptar Vision, Core Values, and Rules of Leadership
Qualifications/Education/Special Skills
- Engineering degree preferred or related discipline
- Minimum of seven (7) years of Quality Engineering or equivalent experience in quality management in a regulated environment with five (5) years of ISO 9001 experience
- Must be an effective leader and have the ability to act with management authority
- Six Sigma Green or Black Belt
- Proficiency in use of statistical and analytical tools
- Proficiency in use of FMEA’s, Control Plans, and Risk Assessments
- Proficiency in use of RCA’s and DOE’s
- Certified Internal Auditor
- Working knowledge of ISO 9001 and ISO 13485
- Facilitation and listening skills are a must
- Ability to resolve interpersonal conflict and team build
- Ability to work effectively across all organizational levels
- Ability to influence management on courses of action with minimal assistance through written and verbal communication
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