Director, Quality Systems, Medical Device

The Director of Quality Systems has operational responsibility for Quality Assurance within CSC global sites; working closely with various functional areas to meet established quality requirements, as well as implementing and supporting processes to support organizational quality as identified in CSC's Quality Management System. This position is directly responsible for the management of CSC's QMS, supplier quality, reliability engineering and monitoring, and management of the Corrective and Preventative Action (CAPA) system. The Director of Quality also develops and implements employee communication and training programs in connection with the company's overall process improvement objectives, strategies, and processes.

Responsibilities:

• Communicate and support quality policy and philosophy throughout company global sites.
• Manage day-to-day operation of the department and establish the overall priorities, objectives, standards and measures.
• Assist to deploy and maintain plans designed to continually improve products and services through the implementation of recognized quality management standards, process improvement strategies and demonstrated best practices.
• Organize and promote company wide quality improvement efforts. Evaluate and develop improved techniques for the control of quality and reliability.
• Coach, support and provide individual assistance to key leaders to assure understanding and acceptance of process improvement as a way of doing business.
• Manage continuous improvement program, establishing and maintaining quality assurance standards, procedures and controls in support of industry standard certifications (i.e. ISO 13485 and TS 16949).
• Train employees in process improvement methods (including problem solving skills) and/or recommend expert resources to support organizational needs
• Collaborate with the Supply Chain Organization on supplier management initiatives.
• Work with teams to develop and institutionalize a standard approach to Process improvement System Tools (such as System FMEA, Design FMEA, Process FMEA, Control Plans, DVP&R, Reliability, Six Sigma etc.) throughout all product development and manufacturing phases.
• Establish key performance indicators and ensure that effective and closed-loop corrective and preventive action systems are in place.
• Serve on business excellence council(s)
• Overall responsibility for the Supplier Quality program.
• Oversight and management of issues related to suppliers and contract manufacturers to solve quality problems.
• Development of quality plans for new products.
• Oversight of failure investigation to support complaint process and reliability improvement for sustaining products.
• Participate in acquisition Due Diligence and subsequent integration activities as required.

Qualifications:

•  Bachelor's degree, preferably in a technical or scientific field, with a minimum of 8 to 10 years experience in Quality Assurance and Quality Engineering in a GMP environment with at least 5 years of supervisory experience.
• Strong knowledge of statistical methods (certification in Six Sigma methods a plus), including reliability/survival analysis
• Experienced in applying the classic Quality Tools for process improvement and root cause analysis
• A working knowledge of US FDA QSR, IOS 13485 and JP GMP regulations is required.
• Experience in Quality Systems implementation, auditing, and enhancement.
• The ability to lead the quality function in a fast paced, high growth, environment.
• Experience leading through critical junctions, overcoming quality hurdles to resolve challenging situations.
• Strong management skills characterized by setting appropriate expectations, monitoring delegated activities, and providing recognition for results
• A commitment to developing subordinates' skills and encouraging professional development.
• A personal style, negotiating skills, and level of business acumen to effectively interact with company and government personnel at all levels.
• An inclusive style for planning, decision-making, facilitating and process improvement. The creativity and flexibility to change course based on the feedback of peers and market information.
• Innovative thinking and intelligent risk-taking skills with a high degree of independence to proactively prioritize, and deliver commitments.
• Outstanding communication skills, including presentation skills and the ability to influence superiors, peers, and subordinates.
• CQE or CQM status strongly desired
• Active member of ASQ a plus
• Experience with MiniTab a plus.