Quality Engineer
IntePros is currently looking for a Quality Engineer - New Product Introduction to join one of the Leading providers of integrated pharmaceutical development Services in Philadelphia, PA.
The Quality Engineer is a key, customer-facing role that will be responsible for the onboarding and support of new customer programs for the Philadelphia Site.
The QE will be responsible for the transition of new products and processes from engineering to manufacturing and the supply chain.
This position will work closely with product engineering to define manufacturing requirements within the New Product Development process including all phases in Design for Assembly (DFA) through to Design for Manufacturing (DFM).
The Quality Engineer will interact and collaborate with internal team members, customers, suppliers, and contract service providers.
The position will be responsible for driving timeline commitments for new projects.
The Quality Engineer will also function as a technical resource in deviations, defect analysis, complaints, establishing sampling plans, assessments, and protocols.
Quality Engineer
Responsibilities:
Technical (Product and Process) Drive and support new customer programs throughout the development lifecycle and deliver on the 'One client' customer experience and program management Interact with clients on an as-needed basis to support project milestones, scope changes and business development opportunities.
Develop and implement product and process workflows to ensure best engineering practices within the quality and engineering teams for DFA/DFM (DFMA) into sustainable engineering and commercial operations.
Test method transfer or method validation activities.
Development of sampling plans for OQ/PQ activities (includes Serialization and Sterilization activities).
Trend manufacturing data and contract service providers results.
Development of validation/re-qualification protocols.
Development of Master Batch Records, work instructions and associated manufacturing and packaging documentation.
Drive root cause analysis of deviations/complaints.
Support project teams through the selection of correct design / manufacturing concepts and fundamental technology to ensure successful project outcomes.
Develop work standards and packages as part of project acquisition process and following subsequent project delivery stages, to successfully deliver projects within scope, with quality, and within allocated timeframes and budget.
Identify opportunities and develop recommendations to improve product and process design.
Interpret product requirements and design and develop concepts, components, assemblies, and products in compliance with applicable quality system procedures, industry, and business standards.
Supports the generation of documentation such as Measurement System Analysis (MSA), Control Plans, Process Flow Maps, Inspection plans and techniques, GR&R & test requirements.
Maintain QE process discipline to achieve project deliverables, including but not limited to, supporting manufacturing strategy, capability analysis, FMEA, tooling selection, risk management, supporting cost modelling, DFM, and process validation/qualification.
Employ data driven tools and methodologies to implement structured and timely problem.
Development and/or review of technical specifications Supplier Quality Participate in External Audits of Suppliers/Contract Service Providers.
Manage internal and external suppliers required to support product design tasks.
Leadership Collaborate with the engineering, business development and ancillary groups and wider development, manufacturing, and procurement teams.
Attention to detail and self-motivation to deliver work to the highest standards.
Multitasking, planning work, scheduling tasks, coordinating activities, and managing time efficiently.
Timely problem-solving using data driven tools and methods.
Presentation of quality standards, process flows, inspection plans, and/or issues both internally to stakeholders and externally to clients with confidence and accuracy.
Quality Engineer
Qualifications:
Required:
College or Trade Degree required (engineering degree or related scientific degree).
Must have a minimum of at least three years of experience in an FDA regulated industry with strong preference to medical device or combination products.
Demonstrated proficiency with personal computers, business software (e.
g.
, MS Office) and technical software (ERP and eQMS systems).
Ability to create, use and interpret scientific tables, charts, and graphs.
Advanced Computer Skills:
Ability to perform the most complex computer tasks and operate various computer programs.
Full Professional Proficiency:
Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Analytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem solving.
Preferred:
Possesses excellent organizational, time management and multi-tasking skills to meet commitments and deadlines.
Prior experience in technical writing and utilizing root cause analysis tools is required.
Critical thinking skills along with a strong collaborative approach is required.
Lean Six Sigma or other formal process improvement skillsets are highly desirable.
Technical knowledge and experience around Test Method validation, Medical Devices, and Sterilization processes is preferred.
Recommended Skills Acquisition Processes Analytical Assembly And Installation Assessments Attention To Detail Business Development Estimated Salary: $20 to $28 per hour based on qualifications.
The Quality Engineer is a key, customer-facing role that will be responsible for the onboarding and support of new customer programs for the Philadelphia Site.
The QE will be responsible for the transition of new products and processes from engineering to manufacturing and the supply chain.
This position will work closely with product engineering to define manufacturing requirements within the New Product Development process including all phases in Design for Assembly (DFA) through to Design for Manufacturing (DFM).
The Quality Engineer will interact and collaborate with internal team members, customers, suppliers, and contract service providers.
The position will be responsible for driving timeline commitments for new projects.
The Quality Engineer will also function as a technical resource in deviations, defect analysis, complaints, establishing sampling plans, assessments, and protocols.
Quality Engineer
Responsibilities:
Technical (Product and Process) Drive and support new customer programs throughout the development lifecycle and deliver on the 'One client' customer experience and program management Interact with clients on an as-needed basis to support project milestones, scope changes and business development opportunities.
Develop and implement product and process workflows to ensure best engineering practices within the quality and engineering teams for DFA/DFM (DFMA) into sustainable engineering and commercial operations.
Test method transfer or method validation activities.
Development of sampling plans for OQ/PQ activities (includes Serialization and Sterilization activities).
Trend manufacturing data and contract service providers results.
Development of validation/re-qualification protocols.
Development of Master Batch Records, work instructions and associated manufacturing and packaging documentation.
Drive root cause analysis of deviations/complaints.
Support project teams through the selection of correct design / manufacturing concepts and fundamental technology to ensure successful project outcomes.
Develop work standards and packages as part of project acquisition process and following subsequent project delivery stages, to successfully deliver projects within scope, with quality, and within allocated timeframes and budget.
Identify opportunities and develop recommendations to improve product and process design.
Interpret product requirements and design and develop concepts, components, assemblies, and products in compliance with applicable quality system procedures, industry, and business standards.
Supports the generation of documentation such as Measurement System Analysis (MSA), Control Plans, Process Flow Maps, Inspection plans and techniques, GR&R & test requirements.
Maintain QE process discipline to achieve project deliverables, including but not limited to, supporting manufacturing strategy, capability analysis, FMEA, tooling selection, risk management, supporting cost modelling, DFM, and process validation/qualification.
Employ data driven tools and methodologies to implement structured and timely problem.
Development and/or review of technical specifications Supplier Quality Participate in External Audits of Suppliers/Contract Service Providers.
Manage internal and external suppliers required to support product design tasks.
Leadership Collaborate with the engineering, business development and ancillary groups and wider development, manufacturing, and procurement teams.
Attention to detail and self-motivation to deliver work to the highest standards.
Multitasking, planning work, scheduling tasks, coordinating activities, and managing time efficiently.
Timely problem-solving using data driven tools and methods.
Presentation of quality standards, process flows, inspection plans, and/or issues both internally to stakeholders and externally to clients with confidence and accuracy.
Quality Engineer
Qualifications:
Required:
College or Trade Degree required (engineering degree or related scientific degree).
Must have a minimum of at least three years of experience in an FDA regulated industry with strong preference to medical device or combination products.
Demonstrated proficiency with personal computers, business software (e.
g.
, MS Office) and technical software (ERP and eQMS systems).
Ability to create, use and interpret scientific tables, charts, and graphs.
Advanced Computer Skills:
Ability to perform the most complex computer tasks and operate various computer programs.
Full Professional Proficiency:
Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Analytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem solving.
Preferred:
Possesses excellent organizational, time management and multi-tasking skills to meet commitments and deadlines.
Prior experience in technical writing and utilizing root cause analysis tools is required.
Critical thinking skills along with a strong collaborative approach is required.
Lean Six Sigma or other formal process improvement skillsets are highly desirable.
Technical knowledge and experience around Test Method validation, Medical Devices, and Sterilization processes is preferred.
Recommended Skills Acquisition Processes Analytical Assembly And Installation Assessments Attention To Detail Business Development Estimated Salary: $20 to $28 per hour based on qualifications.
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