Quality Engineer - Lean Manufacturing
This position is responsible for supporting quality engineering activities and all aspects of product quality.
This includes participation in the development of new products and processes through commercialization, validation, change management and root cause investigations. Works with various departments to investigate customer complaints. Develops, modifies, applies and maintains quality standards and generates protocols and reports.
Supervision of quality staff to ensure compliance with regulatory standards and customer requirements. Works directly with the quality technicians on product evaluations during the production process, analyzes data from inspection reports and resolves quality problems. Ensures production has the necessary documentation for production runs.
* 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.
* Supervision of the quality department on the daily activities needed to run the quality department.
* Follow Lean Six Sigma (DMAIC) methodology 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 new gauging equipment, new process equipment and products.
* Working knowledge of process flow maps / diagrams, control plans and measurement system evaluations in support of standard requirements.
* Assist in audits (internal and external) by third party registrars and / or customers and maintaining the ISO 9001 and ISO 13485 procedures and work instructions.
* All other duties as assigned.
* Bachelor's degree in a related engineering field such as mechanical, industrial or chemical is required with 5+ years in a Quality Engineering role.
* At least 3 years supervisory 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, DFMEA 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.
Chuck
484-690-9606
chuck@libertyjobs.com
Key Words, Lean manufacturing, six sigma, Continuous Improvement , quality
