Job Description

**Work in conjunction with the US Operations team, R&D, and Sales to develop and drive short and long-term quality strategies to meet business objectives. Effectively lead ongoing quality system improvements in accordance with FHCS 16 Quality Areas System and ensure site QAC Rating of > 85%. Manage supplier audit and assessment program. Lead, manage, and communicate quality metrics for Global and Aurora reports, driving timely resolution of corrective actions and elimination of complaints. **

Responsibilities

• Prioritize, track and drive quality projects using formal project management and quality assessment tools including problem solving and root cause analysis and implementation. Communicate milestone dates and contingency plans if needed.
• Responsible for management of quality requirements associated with the development and launch of new products and product changes, including FAR’s, retained samples, engineering change control and in-process checks, and participate in internal and supplier product development projects from the initial requirements phases through to the QA and deployment phases, and develop necessary methodologies for process and product quality control.
• Author and/or review design input/output/validation documents, product and process specifications, control plans and/or test methods, and develop, implement and train a quality system including risk evaluations, validation of processes/tools/product, FMEA, statistical test design, and statistical lifetime estimation.
• Lead a multi-shift workforce by sourcing and scheduling training, monitoring QMS stability, and cascading information as appropriate.
• Manage and conduct internal/external audits to assure compliance and continual improvement, and review activities for receiving inspection, starting materials release, and process validation.
• Interface with Operations to assure that quality considerations and requirements are adequately covered in manufacturing procedures, equipment selection, design, validation and training.
• Review established corrective actions for non-conformance and ensure timely implementation and effectiveness, and report Aurora Quality KPI’s.

Qualifications

• Bachelor's Degree in an engineering or technical discipline, and/or CQE or other quality and regulatory certificates, preferred.
• 3+ years of relevant prior experience in a Quality leadership position in manufacturing, including experience leading a team.
• In-depth Quality System implementation and execution in compliance with ISO 9001:2015 or a comparable management system.
• On-site process quality engineering or supplier QA consultancy experience, with experience using and facilitating APQP procedures and techniques.
• Experience with the R&D lifecycle with emphasis on QA aspects.
• Experience using Microsoft Office tools and 3D product design tools, with intermediate MS Excel knowledge including pivot tables.
• Our company has a commitment to long term orientation and people development; the perfect applicant will be passionate about continuous development
• of our long-term and high-performing Quality team and is capable of leading a multi-shift workforce.
• Excellent analytical and problem-solving skills with the ability to meet timelines in a fast‑paced environment, and a strong communicator comfortable working both at a desk and on the production floor.
• Experience maintaining and reporting on KPIs.
• Demonstrated application of statistical methods using statistics software (such as Minitab) to set up statistical test designs and run ANOVAs or Weibull analyses. Solid understanding of data and statistics, and quality tools such as gage R&R, design of experiments (DOE), Failure Mode and Effects Analysis (FMEA), and 5 Whys problem solving.
• Bilingual English/Spanish a plus.
• Ability for up to 10% travel to local suppliers.

You should be proficient in:

• Quality Inspection Experience
• 5 Why (Root Cause Analysis Method)
• Advanced Product Quality Planning (APQP)
• Supplier Management
• Quality Control Experience
• Quality Control Data Analysis

Machines & technologies you'll use:

• ERP Software