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.

MAIN RESPONSIBILITIES

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

Reduces and controls distribution process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the 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, implementation of solutions to mitigate risk.

Analyze complex interdisciplinary problems and identifies their impact, establishes probabilities, draws conclusions reflecting broad business needs, understands organizational and financial impact of recommendations, (e.g.,applies regulatory requirements and recommends best course of action).

Responsible for product stops ship execution (containment, releases, disposition executions (scrap, rework, sort).

Develops and implements quality plans, documents and systems by creatingquality specifications, risk analyses, FMEAs in conjunction with other cross functional teams

Responsible for risk analyses and FMEAs of distribution processes.

Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of distribution defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.

Collects and analyzes process defect data (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development.

Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.

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

Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions.

 Interact with business units/mfg site to support product flow or dispositions through distribution Plans and organizes non-routine tasks w/approval.

Initiates or maintains work schedule.

Establishes priorities of work assignments. (Decision Making/Impact) Exercises 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.

QUALIFICATIONS

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 communications to work with highly matrixed organization.  Quality System experience related to implementation and/or maintenance of quality management systems for effectiveness.

Education
Education Level Major/Field of Study or Equivalent
Associates Degree (± 13
years)
Experience/Background
Experience Experience Details
Minimum 4 years

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.