Senior Quality Engineer

Job Summary:

The Quality Engineer 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 into commercial operations. The QE will ensure a successful tech transfer with NPI by directly supporting or driving the tech transfer processes with appropriate cross-functional teams.

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

As a key part of the Quality Team, the QE will work directly with the site leadership and operational teams to assess, analyze, and trend quality of incoming materials (lot to lot variation) to ensure reduction of variation in the product manufacturing process. The QE will be responsible for identifying and containing non-conforming products and driving root cause 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.

Essential Functions:

Technical (Product and Process)

• Drive and support new customer programs throughout the product lifecycle and deliver on the 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 FMEA, into sustainable engineering and commercial operations.

• Trend manufacturing data and contract service providers results.

• Assistance with development of Master Batch Records, work instructions and associated manufacturing and packaging documentation, and the subsequent revision of documents.

• Drive root cause analysis of deviations/complaints.
• Support project teams through the selection of correct 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 products and processes.
• Interpret product requirements and develop concepts, components, 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 modeling, and process validation/qualification.
• Employ data driven tools and methodologies to implement structured and timely problems.

• Development and/or review of technical specifications and Protocols (IQ/OQ/PQ, etc.)

• Participate in External Audits of Suppliers/Contract Service Providers.
• Track and trend raw material and key components to measure variation and part quality over time, in order to drive appropriate and timely improvement with key suppliers.
• Participate in required training events.
• Any and all other duties as assigned.

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 Quality Director. 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.
• Knowledge of and adherence to all Aphena, cGMP, GAMP, 21CFR Part 820, 21CFR Part 11, 21CFR Part 211, ISO9001, ISO13485, procedures, rules, and requirements.