LifeCell develops and markets tissue repair products for use in reconstructive, urogynecologic and orthopedic surgical procedures. LifeCell's leading technologies include: Strattice™, for reconstructive and general surgical procedures; and AlloDerm®, for plastic reconstructive, general surgical, burn and periodontal procedures and Cymetra®, a particle form of AlloDerm suitable for injection.
LifeCell's patented tissue matrix was developed in 1994 as a graft for burn patients. Since then, AlloDerm's versatility has led to its use in many other reconstructive applications, allowing surgeons to restore tissue damaged through injury or disease - using the regenerative power of the patients' own tissues. Position Summary: LifeCell is seeking an Attorney to work in a dynamic, innovative, entrepreneurial spirited environment where together we are transforming surgery. If you are self-motivated, enjoy a challenge and seek satisfaction knowing your efforts are making a difference in someone's life, then this opportunity is for you.
This position reports to the Quality- Process Excellence Manager and is responsible for supporting the implementation of Lean and Six Sigma process improvement initiatives in conjunction with LifeCell and QRTS strategy.
Specific requirements of the position include at minimum:
• Experience with Lean, Six Sigma, Quality by Design (QbD), Design for Six Sigma
• Experience with project execution as leader or as a team member
• Experience with all aspects of Quality Management including Quality Management Systems, Quality Engineering, Quality Assurance and Compliance
• Must have demonstrated the above requirements within a regulated industry (pharmaceutical or medical device)
Under supervision-support medium to large sized Process Excellence teams made up of champion, business lead and functional experts from cross-functional teams
Coach yellow belts and support QRTS improvement initiates and/or projects as needed
Collaborate business process owners to establish project objectives and strategies and implement process improvement projects and initiatives
With supervision support the QRTS strategic planning activities, work with business leaders to determine opportunities for Process Excellence initiatives
Maintain a thorough understanding of the following regulations and guidelines: FDA Good Manufacturing Practices, FDA Good Tissue Practices, AATB Good Tissue Practices, state regulations, ISO 9001, ISO 13485, ISO 14971 standards, , LifeCell corporation policies and procedures, 93/42 EEC Medical Device Directive, and other applicable standards.
Maintain a thorough working knowledge of current and best industry practice within the applicable global regulations and standards to ensure appropriate strategy and best compliance.
Collaborate with the development of Process Excellence training materials for QRTS.
Actively utilize PE tools where leading and/or participating on project teams
B.A./B.S. Engineering/Sciences/Technical required
Other Required Skills:
· Ability to work with functional groups and different level of employees throughout the organization to effectively and professionally achieve business results
· Strong follow-up skills; ability to organize applicable department timelines and follow up with internal and external customer needs as needed
· Strong organizational skills; ability to accomplish multiple tasks within the agreed upon timeframes through effective prioritization of duties and functions in a fast paced environment
· Experience with statistics and statistical software such as, Minitab.
· Ability to support others in the practical use of the Six Sigma philosophy and tools
· Strong written and oral communication skills, including the ability to present ideas and suggestions clearly and effectively
· Experience with process and data analysis tools, DMAIC methodologies and Six Sigma tools
· Applied working knowledge of all aspects of Quality Management including Quality Management Systems, Quality Engineering, Quality Assurance and Compliance
· Must have demonstrated the above requirements within a regulated industry (pharmaceutical and/or medical device)
· Ability to drive results in alignment with LifeCell's vision, mission, and guiding principles
· Bachelor's degree in Business, Management or related discipline, or equivalent work experience is required
· Six Sigma Green belt Certification required
At least 3 years of experience leading process improvements initiatives, with at least 1-2 years in a quality function
Knowledge of Quality by Design (QbD), Design for Six Sigma
Experience with medical devices a plus.
LifeCell Corporation - 22 months ago
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