Title: Director of Quality Assurance and Regulatory
Location: Lake Forest CA (http://1.usa.gov/LifeinLakeForest )
Function: Healthcare: QA/Regulatory/Compliance
Kimberly-Clark (NYSE:KMB) is leading the world in essentials for a better life. Headquartered in Dallas, Texas, with nearly 56,000 employees worldwide and operations in 35 countries, Kimberly-Clark posted sales of $19.1 billion in 2009. Every day, 1.3 billion people trust Kimberly-Clark products and the solutions they provide to make their lives better. With well-known family care and personal care brands such as Kleenex, Scott, Andrex, Huggies, Pull-Ups, Kotex, Poise and Depend, we hold the No. 1 or No. 2 share position globally in more than 80 countries.
I-Flow, a Kimberly-Clark Health Care Company, is improving clinical and economic outcomes following surgery by designing, developing and marketing technically-advanced, low-cost drug delivery systems and innovative products for post-surgical pain relief and surgical site care. More information: http://www.iflo.com/info.php . The subsidiary has an immediate need for Director of Quality Assurance and Regulatory.
• Provide Quality functional and Regulatory Affairs leadership and expertise to Elastomeric Pump and Pain Management Business such that it contributes to the development, manufacture, and distribution of safe and effective products.
• Assure Quality Operations complies with Domestic and International regulatory requirements. Serve as a liaison with FDA or other regulatory agencies.
• Manage and respond to audits by regulators and/or Notified Bodies
• Develop programs and procedures that will provide leadership and direction in assuring successful implementation of staff QA and RA functional systems, and help enhance manufacturing plant prevention-based quality awareness.
• Direct all aspects of plant-based quality including cost process reliability, problem resolution, complaint investigation, document control, CAPA and value improvements.
• Manage product design validation activities to verify that the products are being developed and designed to meet the input requirements.
• Ensure that new products are designed and developed in conformance with internal design control requirements and external regulatory standards.
• Manage the operating expense budget; develop plans for personnel, space and equipment required to meet the demands of the sterility assurance discipline.
• Manage the maintenance of regulatory affairs files such as 510(k)s, device listings, certificates, registrations, and licenses.
Interested? Or perhaps you know of someone that might be, you can apply directly using this link: http://bit.ly/13649-QA-RA-iFLOW . You can also contact Dorothy.Beach@KCC.com to receive more information on job #13649. Sending your resume can allow a more intelligent discussion between your career goals and what Kimberly-Clark needs.
• Bachelors Degree in physical sciences or engineering
• 15 years of management experience in quality systems, product development, and regulatory affairs experience in the Medical Device industry.
• Experience should include in-depth knowledge of all aspects of product realization for medical devices, domestic (FDA) and International regulatory requirements for the medical device industry as well as direct handling of FDA and Notified Body inspections.
Advanced Degree in physical sciences, engineering or MBA.
ASQ certification in Quality Management, Quality Engineering, and Auditing or equivalent.
A good working knowledge of Spanish would be beneficial.