Quality Engineer -Sustaining Engineering (SE)

The Quality Engineer – Sustaining Engineering (SE) is a key, customer-facing role that will be responsible for or support all phases of the product quality lifecycle of the customer program, as the product transfers from NPI into commercial operations. The QE (SE) will ensure a successful design/tech transfer with NPI by directly supporting or driving the tech and design transfer processes with appropriate risk management leadership.

As the new product is fully scaled into commercial operations, the QE (SE) will be responsible for or support all phases of quality operations, ensuring the product is produced according to the established control plan, design, and product specifications, and driving continual improvement to ensure ongoing standardization, simplification, and optimization of the product manufacturing-assembly and final packaging processes.

As a key part of the Quality Operations Team, the QE (SE) will work directly with the site leadership and operational teams to assess, analyze, and trend the quality of incoming materials (lot to lot variation) to ensure the reduction of variation in the product manufacturing process. The QE will be responsible for dispositioning non-conforming products and driving root causes during investigations, with appropriate CAPA to prevent reoccurrence.

The QE will interact and collaborate with internal team members, customers, suppliers, and contract service providers as needed and assist Validation Engineers with validation, qualification, and periodic change assessment activities as required.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Technical (Product and Process)

• 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 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 (including 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 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, and 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 modeling, DFM, and process validation/qualification.
• Employ data-driven tools and methodologies to implement structured and timely problems.
• 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.
• Track and trend raw material and key components to measure variation and part quality over time, to drive appropriate and timely improvement with key suppliers.

Leadership

• Collaborate with the engineering, commercial operations, procurement, and ancillary groups, and wider development, manufacturing, and procurement teams for high-priority product-program initiatives.
• 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.

Other - General

• Attendance to work is an essential function of this position.
• Performs other duties as assigned by the Manager/Supervisor within commercial operations. May assist in the areas of NPI as needed.
• Support the recruitment, coaching, and development of quality engineers to achieve excellence and efficiency when programs are scaled.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Required:

• College or Trade Degree required (engineering degree or related scientific degree preferred). Must have a minimum of at least three years of experience in an FDA-regulated industry with a strong preference for medical devices 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:

• Lean Six Sigma Certification, ASQ Certified Quality Engineer (CQE), or similar certifications are highly desirable.
• 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 are required.
• Technical knowledge and experience around Test Method validation, Medical Devices, and Sterilization processes is preferred.

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