Director of Quality and Regulatory Compliance
Posted on Apr 6, 2021 by IDEX
The Director of Quality & Regulatory Compliance is responsible for (1) providing strategic leadership in global quality, regulatory compliance and environment health & safety activities to ensure continual compliance to US/international regulations and standards; (2) providing strategic direction to the Quality Assurance, Manufacturing Engineering, and Operational Excellence teams; (3) providing strategic quality, regulatory compliance, and technical input to project teams on new product introductions; and (4) developing and presenting quality and regulatory compliance proposals to prospective customers. The position requires extensive interaction and strong liaison activities with internal management teams as well as externally with customers and regulatory agencies. This is the most senior Quality position and a critical member of the Life Science Optics Leadership Team.
The Director Q&RC is responsible for the day-to-day activities of the Quality Assurance, Sustaining Engineering, Continuous Improvement, Environmental Health & Safety and facilities teams. Currently 40 team members
Achieve department goals and metrics in line with monthly and yearly business goals as they relate to Quality, On Time Delivery, Working Capital, Productivity, and Supplier Management.
The Director of Q&RC is responsible for overseeing the Quality Management System in compliance with ISO9001 along with Inspection, Regulatory Compliance (TUV, CDRH, ROHS, REACH, Conflict Minerals, WEEE, 21CFR, IEC 60825-1, and standard import/export regulations), Customer Returns, Supplier Quality and Document Control, design review and production support functions.
This position has the overall authority and responsibility as IDEX Health & Science LSO ISO Management Representative. These responsibilities include:
Ensuring the processes needed for the quality management system are established, implemented, and maintained in accordance with the most recent ISO 9001 requirements.
Periodic reporting to the top management on the performance of the quality management system and any need for improvement.
Ensuring and promoting the awareness of customer requirements throughout the organization.
Responsible for developing and implementing a continuous improvement program for the business to improve both manufacturing and business processes.
Responsible for driving the productivity initiatives of the business to improve labor, burden, and material efficiencies.
Responsible for providing technical support for the day-to-day manufacturing efforts of all product lines at the plant. Driving and improving factory overall efficiency metrics of first pass yield, cycle times, and uptimes.
Support operations management in assessing material and process defects in support of corrective action programs.
In conjunction with the Materials function, actively and continuously pursue improvements in supplier quality, OTD, auditing, and supplier corrective actions.
Direct and oversee the Safety Programs for all Life Science Optics Sites and manage OSHA reporting
Direct and oversee the Environmental Health Policies/Procedures for all Life Science Optics Sites
Direct and oversee the facility preventative maintenance and improvement initiatives
Actively participate in the Management of Daily Improvement (MDI) at the site.
The Director Q&RC must drive initiatives through earning credibility throughout each function of the organization.
EDUCATION AND EXPERIENCE:
B.S. Degree required; advanced degree highly preferred.
Ten or more years in Quality and Regulatory related manufacturing operations management positions with progressively more responsibility.
Prior experience implementing and maintaining an ISO 9001 Quality Management System required - ISO 13485 experience is desired.
Black Belt level Six Sigma/Lean experience preferred.
Experience in low volume/high mix manufacturing required
Knowledge of GD&T is required, experience in optics manufacturing is preferred.
Demonstrated ability to achieve results in a cooperative, cross-functional, participative (eg matrix) environment.
Demonstrated effectiveness in motivating and executing against objectives, policies and procedures through team, including non-exempt associates.
Strong operational excellence background required
OTHER SKILLS and ABILITIES:
Demonstrated ability to understand, plan and execute dramatic change in manufacturing structure, systems and philosophy.
Ability to negotiate, cooperate and effectively interact with peers, superiors, team and vendors to achieve results.
Outstanding demonstrated verbal and written communication skills.
Good ability to use PC & ERP tools for communication, data extraction, and analysis. JDE knowledge a plus.
Ability to independently perform financial and operational assessments of new projects or systems and current activities using PC based software.
Previous experience organizing and driving effective daily management meetings through an organization
Must be able to travel to customer/supplier sites throughout the world.