Quality Engineer – (NPI)

PCI Pharma Services•Philadelphia, PA

20h•Onsite

About The Position

The Quality Engineer - New Product Introduction (NPI) is a key, customer-facing role responsible for onboarding and supporting new customer programs for the Philadelphia Site. The QE will be responsible for transitioning new products and processes from engineering to manufacturing and the supply chain. This position will work closely with product engineering to define manufacturing requirements throughout the New Product Development process, from Design for Assembly (DFA) through Design for Manufacturing (DFM). The QE 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 serve as a technical resource for deviations, defect analysis, complaints, sampling plans, assessments, and protocols.

Requirements

College or Trade Degree required (engineering degree or related scientific degree).
Minimum of at least three years of experience in an FDA-regulated industry, with a strong preference for 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.
Prior experience in technical writing and utilizing root cause analysis tools is required.
Critical thinking skills, along with a strong collaborative approach, are required.

Nice To Haves

Possesses excellent organizational, time management, and multi-tasking skills to meet commitments and deadlines.
ASQ Certified Quality Engineer (CQE) certification is preferred
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 are preferred.

Responsibilities

Drive and support new customer programs throughout the development lifecycle and deliver on the ‘One PCI’ 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 across the quality and engineering teams for DFA/DFM (DFMA) to support 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 the project acquisition process and throughout subsequent project delivery stages to successfully deliver projects within scope, with quality, and within allocated timeframes and budgets.
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 the manufacturing strategy, capability analysis, FMEA, tooling selection, risk management, cost modeling, DFM, and process validation/qualification.
Employ data-driven tools and methodologies to implement structured and timely problem-solving.
Development and/or review of technical specifications
Participate in External Audits of Suppliers/Contract Service Providers.
Manage internal and external suppliers required to support product design tasks.
Collaborate with the engineering, business development, and ancillary groups and wider development, manufacturing, and procurement teams.
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.
Attendance at work is an essential function of this position
Performs other duties as assigned by the Manager/Supervisor within commercial operations (sustainment engineering).
Support the recruitment, coaching, and development of quality engineers to achieve excellence and efficiency when programs are scaled.