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Quality Engineer / Manufacturing /Medical Devices


Lebanon, New hampshire


Quality Engineer / Manufacturing /Medical Devices Job Opening in Lebanon, New hampshire - POSITION : Quality Engineer / Manufacturing /Medical Devices
POSITION TYPE : FULL TIME / PERMANENT
REPORTS TO: Quality Assurance Manager
PAID RELOCATION: YES
JOB DESCRIPTION: .
The Manufacturing Quality Engineer is responsible for ensuring the quality of all products, quality system documentation, manufacturing process quality and customer problem resolution.
Investigates product customer complaint cause, root cause analysis and submits corrective action plans. Performs daily 5S and process audits of specific injection molding machines against the Master Process and Control Plan. Participates in and assists in problem resolution with customer on-site quality issues and/or quality term career growth opportunity.. Competitive salary and benefit package. Company paid relocation package.
JOB DUTIES :
Participates in product design reviews and Engineering hand-off approval.
Resolves internal product quality problems to reduce defects/scrap.
Investigates product customer complaint cause, root cause analysis and submits corrective action plans.
Participates in and assists in problem resolution with customer on-site quality issues and/or quality reviews.
Oversees and supports Quality Technicians.
Performs specific quality training for Quality Technicians, IPI?s, and Manufacturing Quality Technicians.
Develops and maintains QAR?s (part specific work instructions).
Performs daily 5S and process audits of specific 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.
QUALIFICATIONS:
Engineering or Science degree preferred but will consider candidates with equivalent industry experience.
Minimum of 5 years quality engineering experience, with specific experience in medical devices/components desirable.
Experience with quality systems such as ISO, TS or FDA.
with measurement equipment.
Computer literate in programs such as Word, Excel, and PowerPoint., Minitab, Mathlab or other similar software.
Solid statistical knowledge and practical experience.
Knowledge and experience in control plan development, product print and specification understanding.
Customer interface experience.
Knowledge of molding process and procedures desired.
Certified Quality Auditor and/or Quality Engineer highly desirable.
Job Type: Full-time
Required experience:
Quality Engineer: 5 years
ISO, TS or FDA systems: 5 years

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