Quality Engineer

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : Elkton, Maryland

Post: Fri, 09 Sep 2022 03:29:21 GMT

Expires: Fri, 07 Oct 2022 23:59:59 GMT

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—————————— Job Description ——————————

Roles & Responsibilities:

Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration.

Maintain documentation associated with packaging/manufacturing processes.

Provide technical support for production packaging/labeling tools and software including assembly/sealing equipment and automation.

Follow established guidelines and management direction with regard to engineering decisions.

Advise leadership of developments which may affect schedule and costs.

Participate on projects to concurrently develop packaging assembly methods, tooling, equipment and processes for new and existing products.

Partner with Manufacturing to develop lean principals to implement solutions for product packaging, labeling and sealing/assembly.

Create standardized work and process maps that result in an optimized production system and extended value stream.

Conduct, coordinate and aid in formal Process Validations including protocol development and execution.

Support line validation / qualification activities for including IQ, OQ , MSA and PQ

Support project team members in achieving business objects related attainment of Safety, Quality, Service, and Project Schedule and Cost goals.

Follow established procedures to perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Equipment Installation, Characterization, Qualification and Validation activities.

Interactions with manufacturing providing hands-on support and responsibility for metrics such as labor time, lead-time, capability, and yield.

Provide detailed engineering analysis and documentation in the management of material disposition, process updates, Client’s and CAPA.

Perform root Cause Analysis (RCA), Client and CAPA responses.

Complete on time project updates, development plans, self-assessments, and successful completion of all training requirements.

Application of statistical and analytical methods such as SPC, SQC and DOE.

Contributor to the Capital Expense Request (CER) process, specify cost for packaging/labeling/sealing equipment with consideration to product standard cost targets and capacity demands.

Contribute to continuous improvements in overall product cost and quality.

Education & Experience:

Strong leadership skills and able to take direction

Knowledge of Lean and/or 6 Sigma

Knowledge of GD&T

Knowledge of DFMEA and PFMEA

Strong Interpersonal Skills

Strong Computer Skills

Strong Project Skills

Knowledge and Experience with packaging, assembly and manufacturing methods/equipment (ie: Sencorp bar sealers, Alloyd blister sealers and material sealing of PETG to tyvek, foil to tyvek, foil to foil, mylar to Tyvek) and Vision Systems.

Knowledge and Experience with packaging material process and testing.

Engineering and Problem solving tools: MINITAB, SIX SIGMA, DOE, GR&R, CAPA, CAD, DMAIC

Experience with DFMA and Lean manufacturing tools.

Excellent organization, Planning, Computer skills, Technical writing, Communication and Presentation skills.