Quality Engineer

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The Quality Engineer position leads corrective action and continuous improvement activities in support of the company’s quality vision and strategy through routine, direct cross-functional interactions. The position also works with the design team and customers to qualify new products and processes.
Assists in implementing, maintaining, and auditing company quality systems to ensure ongoing effectiveness.
Interacts daily with quality and production associates at their workstations to facilitate continuous improvement through observation of work, training, and knowledge transfer.
Provides support for internal and external quality issues and assists in driving timely and effective corrective actions.
Communicates quality issues to production personnel through various work aids (special instructions, quality alerts, direct training, etc.).
Coordinates, reviews, and submits validation packages, First Articles, PPAPs, and sample parts for customer approval within prescribed lead times.
Develops and maintains control and inspection plans for primary and secondary operations as well as incoming materials and components, ensuring alignment with established standards and specifications.
Other duties and assignments as directed by Management.
Must demonstrate effective listening, sound judgment, be well organized, take initiative, and work well under pressure.
Highly adaptive and flexible to accepting new ideas, people, procedures, and processes.
Problem Solving/Analysis – ability to apply concepts such as quality engineering statistics, fractions, percentages, ratios, and proportions to practical situations. Strong analytical skills to make quantitative projections.
Results Driven – in support of established KPI’s and Quality Objectives
Technical Capacity – thermoforming and quality related (metrology, standards, specifications, qualification processes, etc.).
Language skills (English) – ability to read, analyze and interpret general and technical business documentation, write reports, business correspondence, manuals, procedures, and work instructions. Ability to effectively deliver information through presentations and respond to questions from all levels, internally and externally.
Reasoning Ability – solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Ability to facilitate resolution of complex issues.
Proficient user of Microsoft Office products including Word, Excel, and PowerPoint is ideal.

Bachelor of Science Degree in Quality Engineering (or related business)
Practical Experience – 1-3 years

Possess technical knowledge in quality specifications and standards.
Proficiency in MS Office Applications especially Excel, Word, Power Point
Preferred Qualifications: cGMP/cGDP Experience (preferred)
Quality Engineering (i.e. DOE, Inference Tests, Normality/Capability Analyses, Correlation Studies, Gage RR, etc)
Information Analysis (Mini-Tab experience preferred)
ISO 9001 / ISO 13485 (preferred)
Prior use of measuring tools such as: calipers, micrometers, go/no go gauges, and height and depth gauges.
Strong blueprint reading skills and basic knowledge of GD&T (Geometric Dimensioning and Tolerancing). Bachelor’s degree in STEM discipline
PCDMIS CMM programming experience. (considered a plus)
Drawing interpretation and ANSI Y14.5 requirements experience

8-10 hours shift- Monday through Friday.
Requires sitting, standing, and walking.

Validation and calibration knowledge is a must.

The above list of job responsibilities is not exclusive or exhaustive and the post holder will be requiredto undertake such tasks as may reasonably be expected within the scope of the post.
If you are interested in this position, please send a brief cover letter, resume, please state the job title applying for and any other relevant material for the candidacy to . Thank you!
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