Job Description: |
Director, Quality Assurance and Regulatory Affairs – New Port Richey, FL
The Director, Quality Assurance and Regulatory Affairs reports to the Sr. VP of QARA for Pall Industrial in the Western Hemisphere, and is directly responsible for the Quality Assurance function for all of New Port Richey Manufacturing, including development, formulation and implementation of policies, systems, strategic plans/objectives for the management of manufacturing product quality and systems across New Port Richey, establishment of appropriate quality metrics to measure product quality and effectiveness of the quality system, implementation while coordinating priorities and timelines.
Director, Quality Assurance and Regulatory Affairs is also responsible for ensuring Regulatory Compliance, maintaining an effective Internal Audit program, achieve and maintain compliance to appropriate quality system requirements.
Oversight for the implementation and effective management release/distribution of New Port Richeys products ensuring that processes required for the qualification and release of new products are established, implemented, adhered, and maintained.
Ensure that the New Port Richey Quality staff has appropriate skills and organization structure to achieve the business goals, work with the Sr. VP of QARA to develop organization plans in order to close identified gaps in skills and/or resources.
QA site lead for New Port Richey regarding response to all worldwide regulatory agencies on compliance related issues identified through product non-conforming trends, regulatory site visits, and/or field product occurrence.
Build partnerships and collaborates with the commercial/technical business units to ensure the promotion and awareness of customer requirements and quality throughout the New Port Richey site.
As a dotted line reporting relationship to the VP of Global Aerospace Operations and part of the Site Leadership is responsible to collaborate with site organizations to meet key sites performance goals and to address day to day operational issues.
- Design and deploy quality systems and processes to improve focus of the organization for continuous improvement and improved product quality and service to our customers.
- Manage timely resolution of customer issues and complaints to increase customer satisfaction by use of effective root cause analysis to identify and eliminate the sources of customer dissatisfaction.
- Assure effectiveness of corrective and preventive actions provided to our customers to prevent recurrence and reduce DPPM.
- Improve supplier quality management practices to drive continuous improvement of product quality and on time delivery and development of partnerships with key suppliers.
- Increase QA participation in new product introductions and build quality and customer requirements into the process.
- Reduce process and product variability by use of SPC to improve customer satisfaction.
- Manage compliance and maintain active certifications to regulatory affairs and standards including: AS9100C, ISO 9001-2008, ISO 14001, FAR Part 21 and 145, EASA Part 21 and 145.
- Assist in training and coaching of personnel in all functions to understand and comply with customer quality requirements and quality system requirements.
- Perform independent and objective auditing of all manufacturing and service processes to identify nonconformance and systemic failure and drive continuous improvement.
- Leads activities of the New Port Richey Quality function to assure customer requirements are achieved. Successfully manage customer audits and survey requests.
- Enables higher value stream performance by communicating customer expectations and driving reductions in the cost of quality.
- Graduate degree in a technical field such as Electrical Engineering, Mechanical Engineering, and/or Chemical Engineering and/or suitable work experience.
- 6+ years experience leading a Quality function within a manufacturing environment.
- Expertise in achieving and maintaining compliance to ISO 9001 and/or AS 9100C.
- Lean/Six Sigma certification or equivalent work experience or company certification.
- Proven experience and thorough knowledge of quality assurance methods and improvement tools including statistical methods.
We offer competitive compensation, a comprehensive array of benefits, and the opportunity to work with a dynamic team of professionals.
To apply for this position please visit our site at www.pall.com and go to the careers section.
The tracking code for this is HL-121024083109.
Equal Opportunity Employer.
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There is no greater calling or opportunity for a fluid management company than todays challenge – helping customers protect people, the environment and our natural resources. Together we are implementing technologies that purify and conserve water, consume less energy, make alternative energy sources possible and practical, advance medicine and minimize emissions and waste. Our collective efforts are enabling a greener more sustainable future.
Pall is a Fortune 1000 materials science and engineering company with the broadest filtration, separation and purification capabilities in the world. Our process and product enabling technologies help our customers make good products better, safer and even possible. We provide innovative products to customers in health care, biotechnology, pharmaceutical, semiconductor, municipal drinking water, aerospace and industrial manufacturing markets.
Headquartered in Long Island, NY, Pall has operations in every major country.
CareerBuilder - 19 months ago