ESSENTIAL DUTIES AND KEY RESPONSIBILITIES:
- Identifies improvements needed and leads project for implementation. Actively participates in safety, health and wellness initiatives.
- Effectively communicates to all levels of the organization including exempt and non-exempt. Accomplishes this through daily operational meetings, weekly staff meetings, quarterly business reviews, and other mechanisms as determined.
- Utilizes TQM to define the quality organization and systems. Manage the development and implementation of goals, objectives, policies, procedures and systems. Communicates quality goals, metrics and standards to the organization
- Identify quality related organization wide training needs and develops programs. Assist in delivering training.
- Develops customer and final inspection based metrics. Identifies trends and develops action plans.
- Monitors supplier quality performance and initiates programs to ensure suppliers meet organization and customer expectations.
- Coordinates customer non-conformance responses.
- Assists in program launch, machine qualification and equipment validation.
- Develops, implements, and executes a comprehensive gage control plan.
- Performs internal audits.
- Coordinate the improvement of all business systems to maintain TS registration.
- Assists other business units with associate training, accuracy and improved operation of the MRP system.
- Leads Kaizenevents.
- Benchmark industry best practices. Develop and implement programs to promote excellence.
- Ensures compliance with national and international standards and legislation.
- Supervise quality technical staff to ensure technical excellence. Provides leadership for associate relations through effective communications, coaching, training and development.
- Executes plan to enhance profitability, productivity and efficiency throughout the quality department.
EDUCATION and/or EXPERIENCE
Bachelor's degree in quality assurance or related field or equivalent related experience and a minimum of 7+ years of experience in quality engineering in the medical device industry to include quality system experience to include a quality audits (layered process, document, etc), statistical problem solving, statistical sampling technique, SQC, SPC and higher-level statistical problem solving. Experience in Materials Science, material specification and tolerancing and raw material processing technique. Experience with related materials and processes in a high volume precision manufacturing environment. Management and supervisory experiencerequired. ISO 13485 quality system or equivalent experience.
SKILLS, ABILITIES AND OTHER REQUIREMENTS
- Proved track record of reducing costs through processes and efficiencies
- Experience in quality systems. ASQ certification preferred.
- Demonstrated ability to lead Kaizen events and train Lean Manufacturing techniques.
- Planning: ability to perform short and long range planning
- Excellent project and program management skills
- Ability to apply advanced mathematical concepts and apply statistical control techniques.
- Detailed knowledge of principles and practices of mechanicalengineering and design.
- Demonstrated experience in the use of geometric tolerancing and a full range of measurement technique.
- Strong CAD and CMM proficiency
- Skills in budget preparation and fiscal management
Green Belt certified