Act in conjunction with Quality Manager as a technical contact on quality related issues for internal and external customers.
Respond quickly to customer quality issues including performing investigations, apply root cause analysis and problem solving techniques to address concerns. Investigate and document customer non-conformances and corrective actions.
Follow Lean Six Sigma (DMAIC) methodology and other Quality tools to determine root cause of problems and implement sound corrective action.
Development and implementation of quality system documentation and maintenance.
Responsible for leading validation of extrusion processes, new gauging equipment, new process equipment and products.
Working knowledge of process flow maps / diagrams, control plans, PFMEA and measurement system analysis evaluations in support of customer and standard requirements.
Assist in audits (internal and external) by third party registrars and / or customers and maintaining the ISO 13485 procedures and work instructions.
All other duties as assigned.
QUALIFICATIONS / EDUCATION / EXPERIENCE
Bachelor's degree in a related engineering field such as mechanical, industrial or chemical is required with 3+ years in a Quality Engineering role.
At least 3 years experience in a manufacturing environment.
Lean Six Sigma is required; certification is a plus.
Ability to independently apply analytical skills, complex scientific technical principles and detailed knowledge in solving engineering problems.
Clear understanding and application of DOE, and PFMEA methodologies.
Experience with Statistical Process Control methods (control charts, CpK's, etc.).
Knowledge of Good Manufacturing Practices (GMP's) encompassing plastics extrusion lines, calculations of speeds, material composition understanding, comprehension of the basic function of fixtures and familiarity with inspecting and checking methods.
Proficient in Gauge R & R metrology. Ability to read and interpret prints and tool designs.
Ability to troubleshoot / solve problems independently or as part of a team.
Excellent verbal and written communication skills. Ability to, internally and externally, discuss and clearly define key technical and process development issues and independently develop course of action / plans.
Excellent computer skills including Microsoft applications. Minitab or equivalent statistical software. Data base experience is a plus.
Must be hands on and willing to work in production environment including off shifts when projects require.
Ability to travel to division and customer locations to support product and process related projects and quality concerns.
Spanish Language preferred
Ability to read and comprehend instructions, procedures, correspondence and email
Ability to write technical correspondence
Ability to effectively present information one-on-one and small group situations to customers, clients and other employees of the organization.