Quality Engineer

MAIN PURPOSE OF THE ROLE

Provide Process/Quality Engineering and Quality Systems support to distribution activities, helping to ensure delivery of highest quality product to the customer.

Support QMS implementation and maintenance of applicable distribution sites. Activities include documentation updates, new releases of documents, QMS reviews for audit preparation, participation in internal and external agency audits.

Reduce and control distribution process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying primary root causes and implementing corrective and preventative actions.

Execute qualification/validation activities to support distribution projects and internal process implementation driven by the business units.

Own and execute improvement activities (CAPA/NCMR), performing root cause analysis and implementation of solutions to mitigate risk.

Analyze complex interdisciplinary problems and identify their impact, establish probabilities, draw conclusions reflecting broad business needs, understand organizational and financial impact of recommendations, and recommend best course of action with regulatory requirements in mind.

Responsible for product stop‑ship execution (containment, releases, disposition executions such as scrap, rework, sort).

Develop and implement quality plans, documents and systems by creating quality specifications, risk analyses, and FMEAs in conjunction with other cross‑functional teams.

Responsible for risk analyses and FMEAs of distribution processes.

Develop process monitoring systems by identifying critical process steps that could lead to distribution defects and devising methods to reduce process variation to eliminate defects.

Collect and analyze process defect data (e.g., scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis methods to enhance product design and new product development.

Create quality tools and training materials by applying expertise and communicating to respective teams.

Participate in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team.

Participate in determining goals and objectives for projects. Influence middle management on technical or business solutions.

Interact with business units/mfg site to support product flow or dispositions through distribution plans and organize non‑routine tasks with approval.

Initiate or maintain work schedule. Establish priorities of work assignments. Exercise judgment in selecting innovative, practical methods to achieve problem resolution.

Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact.

Minimum 5 years preferred.

Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross‑group dependencies/relationships. Strong verbal communication to work with highly matrixed organization. Quality System experience related to implementation and/or maintenance of quality management systems for effectiveness.

Education Level: Associates Degree (± 13 years).

Experience/Background:
Minimum 4 years.

The base pay for this position is $75,300.00 – $. In specific locations, the pay range may vary from the range posted.