The Manufacturing Quality Engineer is responsible for ensuring the quality of all products, quality system documentation, manufacturing process quality, and customer problem resolution.



Specific Responsibilities

• Participates in product design reviews and Engineering hand-off approval.


• Resolves internal product quality problems to reduce defects/scrap.


• Champions product customer complaint cause and submits corrective action plans in the 8D or customer format.


• Participates in and assists in resolving customer on-site quality issues and/or quality reviews.


• Oversees and supports Quality Technicians.


• Performs specific quality training for Quality Technicians, IPI’s, and MQT’s.


• Develops and maintains QAR’s (part specific work instructions).


• Performs daily 5S and process audits of select injection molding machines against the Master Process and Control Plans.


• Verifies and validates reports after mold repair, including capability studies, gauge R & R’s, first article reports, etc.


• Annually revalidates medical/automotive components per customer requirements.


• Develops and maintains SPC database for medical components.


• Performs daily inspection of product/process on the production floor.


• Supports internal Audits, Customer Audits, and ISO/QS Audits.


• Assists in procedure development and/or maintenance.


• Responsible for MRB disposition of nonconforming products in the absence of the Quality Manager.


• Other duties as assigned.

Qualifications

• Engineering or Science degree desired.


• Minimum of 5 years’ quality engineering experience, with specific experience in medical devices/components desirable.


• Knowledge/experience with measurement equipment.


• Computer literate in programs such as Word, Excel, and PowerPoint.


• Solid statistical knowledge and practical experience.


• Knowledge and experience in control plan development, product print and specification understanding, and customer interface experience.


• Knowledge of molding process and procedures desired.


• FDA/ISO/TS system knowledge and experience.


• Good communications skills.


• Ability to lift up to 50 pounds.


• Certified Quality Auditor and/or Quality Engineer highly desirable.


• Ability to travel when needed (less than 5% of the time).