Quality Assurance Engineer
Company: Drucker Diagnostics
Location: Philipsburg
Posted on: February 25, 2021
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Job Description:
General Summary:This position supports all aspects of Quality in
regards to the company processes, product designs, in-house
manufacturing of components, and supplier quality in addition to
ensuring corporate regulatory compliance to FDA CFR 820 and ISO
13485 standards.Design, install, and evaluate quality assurance
systems and procedures to assure the highest level of product
quality for the company; design or specify inspection and testing
mechanisms and equipment; analyze production and service standards;
recommend revision of specifications when indicated; formulate or
help formulate quality assurance policies and procedures and assist
in their implementation.Lead Quality investigations by
troubleshooting component failures, nonconforming materials, and
product failure either during manufacturing or after the sale. Work
with suppliers to drive continuous improvement from approved
suppliers, address non-conforming materials, drive incoming
inspection activities to the supplier, and focus on reducing cost
of Quality by reducing required Quality Control inspections.Provide
input to Manufacturing Engineering to ensure manufacturing methods,
systems, and processes produce the required level of quality.
Implement workflow enhancements to improve plant wide production
Quality thereby reducing cost and increasing profits. Develop,
evaluate, and improve manufacturing methods with a focus on Quality
by utilizing knowledge of product design, materials, fabrication
processes, tooling, equipment capabilities and assembly
methods.Provide input to Design Engineering to ensure product
designs, design systems, and design processes produce the required
level of quality.Keep abreast of industry standards related to
corporate responsibility and compliance practices, as well as
regulatory news that could affect the company's business activities
regionally, nationally, or internationally.Essential Duties and
Responsibilities:* Improve operational quality and reduce scrap,
through incorporation of 5S and lean manufacturing practices*
Analyze manufacturing process flows for the enhancements of
quality, cost reduction, and throughput while maintaining quality*
Conduct or supervise investigations to determine root cause of
failure and participate in or make recommendations for corrective
actions* Assist in design, layout, and installation of jigs,
fixtures, and production equipment needed to improve quality.*
Develop quality control test procedures, test criteria, and
inspection techniques for supplier components and finished goods*
Complete and properly document projects and implement systems
procedures and policies to improve product quality and
manufacturability leading to improved quality.* Participate in
on-site quality system audits of critical or problematic suppliers*
Conduct training on quality assurance concepts and tools to the
organization* Assist in the development of forms and procedures for
the quality system* Update and maintain job knowledge by
participating in educational opportunities and reading professional
publications* Assist in design and engineering of equipment,
facility, and flow paths to optimize total quality* Provide
regulatory expertise and support as required by the
organizationSupervisory Responsibilities:* May oversee Quality
Technicians or other Quality Assurance rolesQualifications:*
Demonstrated leadership abilities and strong business acumen*
Experience with Quality System Documentation and good manufacturing
practices* Exceptional prioritization and organizational skills *
Strong project management skills and robust research and reporting
capabilities* Strong interpersonal skills: ability to work in a
cross-functional, project team environment* Excellent writing,
reading and documentation skills including record maintenance/
tracking and understanding of document traceability* Demonstrated
ability to work accurately, follow instructions/schedules/timelines
and handle multiple priorities* A detail-oriented individual, with
a "can do" attitude, and the ability to work in a team environment,
as well as individually (with minimal supervision)* Quality
Engineer Certification (CQE) from ASQ or equivalent is desired*
Strong knowledge of ISO 13485 Quality Systems, FDA, EU Directives
and general QSR concepts and guidelinesEducation and /or
experience:* Bachelor's of Engineering or equivalent experience
working in a laboratory or medical device manufacturing environment
preferred. Experience in FDA regulated environmentsDesired:*
Specific experience in applied manufacturing, design, and
development of regulated products with a focus on quality or
Regulatory Affairs field concerning medical devices* Experience as
a compliance engineer focusing on safety, EMC, Radio, Energy
Efficiency, international regulatory certifications, or a similar
discipline with 3 or more years of laboratory or medical device
experience* Experience with ISO and/or FDA compliance requirements*
Lean manufacturing, 5S, and single piece (cellular) assembly
experienceLanguage Skills:* Excellent written and verbal
communication skills required to seamlessly work across groups at
all levelsComputer skills:* Working knowledge of Microsoft Office
Suite, particularly Excel and Word* Experience with ERP
environments (specifically Epicor) a plus* Good statistical
knowledge and application skills* Minitab experience a plusPhysical
demands:* Ability to lift up to 50 poundsWork environment:* Office
and Manufacturing EnvironmentTravel requirements:*
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Keywords: Drucker Diagnostics, Pittsburgh , Quality Assurance Engineer, Engineering , Philipsburg, Pennsylvania
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