Quality Engineer (Architecture)
ESSENTIAL DUTIES AND RESPONSIBILITIES
- 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.
LANGUAGE SKILLS
- 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.
