Quality Manager

Placon Corporation•Elkhart, IN

About The Position

The Quality Manager is responsible to provide leadership to insure Placon's compliance with the many standards by which we operate our business. Additional responsibilities include the creation and management of our business systems that comply with and support standards such as ISO, SQF, IMS, GMP and training of these systems throughout the organization, providing management level leadership in the New Product Development (NPD) system and manufacturing process development support and designing and leading the implementation of effective quality plans, process control plans and process improvement. Essential Accountabilities Manage the Quality team (Engineers, Specialists, and Technicians) by coaching, counseling, mentoring, appraising performance, selecting, orienting and training team members. This includes developing effective quality related training courses and job expectations to support our quality systems. Develop their individual functional capabilities to provide excellent service to our internal and external customers. Manage and provide expert leadership regarding ISO, SQF, GMP and IMS compliance and certifications per site specific requirements. This also includes leadership over and maintaining current certification status as our Quality Systems Management Representative. Facilitate compliance with these standards in all departments & facilities by working with individual department and facility managers regarding their work instructions, procedures, documentation control and training records to ensure compliance with the overall Corporate Quality System. Manage all internal audits including product safety audits including assignment of the audit teams and areas. Responsible for all site-specific quality system related audit planning, scheduling and execution including follow up with any actions as a result of the audits. This includes all third-party certification audits, internal audits, regulatory audits and customer audits. Manage the efforts of the Quality team to provide support services for NPD including product specification development, prevention planning e.g., PFMEA and DFMEA, lead statistical studies with executive summaries, DOE, IQ-OQ-PQ, measurement and test methods, GR&R studies, and participation in Design reviews to represent the quality department. Direct the activities of the Quality team in the development, implementation and administration of process control plans for manufacturing. These include Incoming inspection, Inspection and test of products/processes, SPC, support measurement hardware and software, work methods and set up procedures, training in work instructions, standardization of processes and capability studies, prepare executive summary reports of SPC data. Manage the efforts of the Quality team in CA/PA investigations including preliminary investigations for customer incident reports, recording and tracking systems, utilize root cause analysis tools, communication with the customers regarding issues and resolution, investigation and determination of root cause analysis, and participation in prevention planning teams. Develop and present training for process leaders and team members in the application and use of statistical tools for process measurement, problem solving and process improvements. Provide training in systems thinking, root cause corrective action and prevention of potential non-conformances. Develop and implement quality auditing and measurement systems to evaluate product and process quality including product recall, calibration, gauge design, GR&R studies, product and process validation and verification. Develop and maintain systems for measuring and monitoring the quality of sourced materials and the supplier's quality performance. This includes leading and coordinating supplier audits as necessary.

Requirements

Bachelor's degree in a technical discipline including Engineering, Quality, Mechanical, Electrical, Industrial Technology or Industrial Management.
Three years' experience in a quality engineering or a process engineering role or equivalent role in a manufacturing environment.
Two years of formal experience in ISO and GMP certification standards.
For Sites producing food packaging, 2 years of Food Safety experience, HACCP, and GFSI certification (SQF preferred).

Nice To Haves

Knowledge of the application of statistical tools for problem solving, process measurement, process control and process improvement processes.
Familiarity with SPC hardware and software for process measurement studies and statistical analysis.
Knowledge of Microsoft Office Suite.
Must be able to plan and direct one's own work with minimal general direction from others.
Active involvement in professional quality organizations such as ASQ.
Prior experience in the plastics or packaging industry
Demonstrated ability to provide leadership in quality systems, including ISO.
Ability to communication effectively both verbally and in writing
Demonstrated expertise and knowledge of GMP's, FDA regulations, SOP implementation as well as an understanding of quality control principles and QA audit functions.
Demonstrated experience working at all levels of an organization.
Ability to positively interact with customers, vendors and 3rd party auditors.
Understanding of financial and business principles
Experience with ISO 13485
Medical packaging experience
Clean room experience
New product introduction experience

Responsibilities

Manage the Quality team (Engineers, Specialists, and Technicians) by coaching, counseling, mentoring, appraising performance, selecting, orienting and training team members.
Develop effective quality related training courses and job expectations to support our quality systems.
Develop their individual functional capabilities to provide excellent service to our internal and external customers.
Manage and provide expert leadership regarding ISO, SQF, GMP and IMS compliance and certifications per site specific requirements.
Facilitate compliance with these standards in all departments & facilities by working with individual department and facility managers regarding their work instructions, procedures, documentation control and training records to ensure compliance with the overall Corporate Quality System.
Manage all internal audits including product safety audits including assignment of the audit teams and areas.
Responsible for all site-specific quality system related audit planning, scheduling and execution including follow up with any actions as a result of the audits.
Manage the efforts of the Quality team to provide support services for NPD including product specification development, prevention planning e.g., PFMEA and DFMEA, lead statistical studies with executive summaries, DOE, IQ-OQ-PQ, measurement and test methods, GR&R studies, and participation in Design reviews to represent the quality department.
Direct the activities of the Quality team in the development, implementation and administration of process control plans for manufacturing.
Manage the efforts of the Quality team in CA/PA investigations including preliminary investigations for customer incident reports, recording and tracking systems, utilize root cause analysis tools, communication with the customers regarding issues and resolution, investigation and determination of root cause analysis, and participation in prevention planning teams.
Develop and present training for process leaders and team members in the application and use of statistical tools for process measurement, problem solving and process improvements.
Develop and implement quality auditing and measurement systems to evaluate product and process quality including product recall, calibration, gauge design, GR&R studies, product and process validation and verification.
Develop and maintain systems for measuring and monitoring the quality of sourced materials and the supplier's quality performance.