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Manufacturing Quality Engineer Location: US-VT-Bethel Jobcode: 3edb91c700a10751b7e90542d30e73f4-122020 Email Job
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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).
Stark HR Consulting LLC
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