Director - Quality Systems - KIK Custom Products - Elkhart

Job description

Site Overview
This position is located at KIK's Custom Division Headquarters in Elkhart, IN. Our Elkhart, Indiana plants collectively contain 10 aerosol lines, 7 liquid lines, 3 tube lines, and 2 packaging lines. KIK Elkhart procures, blends, fills and packages a wide variety aerosol and liquid personal care, pharmaceuticals, and OTC consumer packaged goods



The Director Quality Systemsis responsible and accountable for developing, applying and maintaining quality standards for company products with adherence to both internal and external standards. This critical quality leadership position reports to the President, Custom Division, and pro-actively manages expectations, business needs and competing demands of external customer and internal stakeholders.

Essential Job Functions:

In support of the quality system, provide effective leadership support, training and guidance to all company personnel
Identify and leverage best practices across the Division for Custom Division's Quality Systems
Responsible for company’s product quality and reliability to meet or exceed customer expectations
Assure compliance to all government/agency regulations, customer requirements and KIK quality systems.
Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization.
Work closely with product and project managers on the implementation of new projects and infrastructures including operational readiness, change preparation, change execution, and post-change QA validation.
Introduce, develop, maintain, and periodically update QA Procedures.
Work with the QA organizational structure of each facility to help identify the facility's issues.
Works with procurement, assisting in the development of new/existing supplier capability.
Maintains working relationships and partnerships with suppliers to effectively provide materials that improve quality, improve efficiency and reduce cost.
Participate in quality auditing activities including external (regulatory body) audits, supplier audits, customer audits and internal KIK audits.
Acts as SME for harmonization of all systems throughout Custom Division
Performs other tasks as required under the direction of the President, Custom Division

Desired Skills and Experience

Bachelors Degree in related Technical discipline
7+ years experience leading Quality / Quality Systems
Experience in Medical Devices, Pharmaceuticals, or OTC (Over The Counter) industry standards,
Regulatory knowledge; ideally CFR TITLE 21 PART 211, Current Good Manufacturing Practice For Finished Pharmaceuticals and PART 820, Quality System Regulation
Experience in assessment, root cause analysis, internal investigations and customer complaint resolution process, Document Management Change and Control, Fullfilment Activities
Experience driving quality process harmonization across multiple facilities
Experienced in training and staff development
Collaborative leader w/ability to assemble project teams and corrective actions teams
Problem solving and influencing skills. Must be a tactfully tenacious, highly responsive and diplomatic relationship builder.
Travel appx 25% -30%, primarily for audits and training

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