Development Quality Engineer

Summary:

Primary duties are to provide quality engineering support of the Development/NPI team s includes the support and documentation of validation activities, ensuring compliance to industry and regulatory standards, development and qualification of measurement methods, and supporting the implementation and qualification of new product lines. The engineer should be comfortable working within a team, have a strong attention to detail, and be able to accommodate multiple projects simultaneously.

Duties/Responsibilities include but are not limited to:

Lead root cause analysis of manufacturing process issues encountered during the development cycle

Facilitating the creation of process failure mode and effects analysis

Authoring:

Process flow charts

Master validation plans

Process qualification protocols and reports

Test plans

Process failure modes and effects analyses

Sampling strategies

Test method validation protocols and reports

Work instructions

Control plans

Assist inspection associates in the creation of receiving inspection instructions.

Represent quality team in project meetings and completing assigned tasks on time.

Capability analysis of process, test, and qualification data.

Competencies/Talents/Personal Attributes:

Communicates effectively

Ability to present information to all levels within the organization

Strong math skills with ability to understand descriptive and inferential statistics.

Ability to read blueprints, recognize UL specifications and understand geometric dimensioning and tolerancing (GD&T).Demonstrates a basic understanding of ISO 13485 and GMP requirements.

Ability to understand material characteristics, tooling specifications, equipment, and how materials, tooling, and process settings interact to affect the overall tolerance capability of various product designs.

Ability to balance the requirement for meeting customer expectations and FDA regulations with company profitability in supporting the Quality Technician in developing estimates for work and inspection instructions.

Excellent attention to detail.

Basic understanding and application of Six Sigma (DMAIC) manufacturing concepts and Lean concepts.

Ability to determine appropriate inspection tools to be used i.e. fixtures, templates, coordinate measuring machine, and go-no go gauges, etc.

Ability to create and sustain effective relationships both internally and externally.

Four-year Bachelor of Science/Engineering degree

Alternatively, a demonstrable 10-years of progressively responsible work experience in a technical manufacturing Quality role supporting Quality Engineering Or a two-year technical degree and demonstrable 6-years of progressively responsible work experience in a technical manufacturing Quality role supporting Quality Engineering2 years of medical manufacturing experience (may include internship experience)
Experience in an automated manufacturing and testing environment. Rotary converting a plus.

Proficient PC skills in Mini Tab and Microsoft Office.

CAD modelling experience preferrable.

Able to utilize GD&T software packages highly desirable.

Engineering experience in medical device contract manufacturing.
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