The Director, Quality Engineering is a key member of the Quality Management Team with responsibility for an operating budget and Strategy, and reports to the Vice President of Quality, Regulatory Affairs and Tissue Services. He or she manages a team of quality engineers that are responsible for planning, leading, and managing of essential daily and project oriented activities related to actively ensuring Quality within LifeCell products. Areas of responsibility include: Quality strategy for new products, product commercialization support, design control, product and process risk management, postmarket product reviews, and Quality improvement strategies and projects. The incumbent interfaces primarily with Medical Affairs, Research and Development, Project Management, Regulatory Affairs and Commercial Operations to apply best practices, incorporate risk based decisions as related to product quality and safety, and incorporate Quality by Design principles into process changes and new products.
The position is also responsible for direct staff performance, development, Product Development program metrics, budget management and setting/driving overall Quality organizational goals.
Act as an advocate for LifeCell Quality. Manage daily activities, staff, and use of Product/Process Risk Management policies and procedures to ensure high Quality and Safety of products. Responsible for Product Risk Management key performance metrics and driving continuous improvement. Ensure data is adequately included and evaluated in Post Market Surveillance procedures.
Manage the Quality representation, input and review for New Product Commercialization Teams to ensure overall Quality Compliance and Business Goals. Ensure Quality by Design principles and Design Control to facilitate successful product transfers, design changes, and robust post market production. Utilize and continuously improve LifeCell Product Commercialization Process Procedures.
Lead and champion Process Excellence programs and projects within Quality utilizing six sigma, lean, DMAIC, and bench marking tools for Quality Processes and Systems. Actively participate in industry groups and LifeCell Process Excellence Programs/Committees.
Manage and ensure adequate technical and statistical review of Quality Documentation as related to Design Controls, Production Support, Process Excellence, and Risk Management. This includes but is not limited to NCRs, Deviations, Verification & Validation Protocols, GMP/GTP Data, and Reports, Design History Files and associated documents, change requests.
Responsible for staff performance, development, and resource allocation in areas of direct responsibility to meet Quality and LifeCell goals.
Build strong cross functional partnerships with R & D, Marketing, Medical Affairs and Project and Portfolio Management to support Quality and LifeCell goals.
Act as a senior leader and mentor to Quality staff. Participate on Quality Sr. Management staff. Participate in building and implementing Quality's strategic plan and annual budget.
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. Actively participate in industry groups to understand future changes.
Represent areas of responsibility during regulatory and third party audits.
B.A./B.S. In Engineering/Sciences required. Minimum 7 years of experience in quality/manufacturing operations,and five (5) years of Process Improvement / project experience
Other Required Skills:
Six Sigma Certification
Design Control (Global)
Certified Quality Engineer (CQE)
Certified Quality Auditor (CQA)
Certified Manager of Quality/Organizational Excellence (CMQ/OE)
Continuous Improvement/Six Sigma/ LEAN
PMI or equivalent certification preferred.
Experience with medical devices.
Experience in Oracle reporting and tools preferred.
LifeCell Corporation's portfolio of products includes our well-known soft-tissue repair products for abdominal wall reconstruction, breast...