Provides oversight of design control activities, design and technology transfer to manufacturing, risk management program and process validation activities. Coordinates overall quality activities for product development programs/projects, ensuring compliance with WWQA standards, AGM Design Control and Risk Management SOPs, and regulatory requirements (CFR 820, ISO 13485, ISO 1497). Provides quality engineering guidance to product development teams throughout the product development process to ensure appropriate PDP deliverables, resulting in the development of safe and effective medical devices.
Provides oversight of R&D new product programs/projects as it relates to design and development, technology transfer, and process validations. Serves as the Quality representative on all R&D programs/projects.
Utilizes Design for Six Sigma methodology/tools to promote a disciplined approach to product and process design in order to ensure product quality and process capabilities.
Reviews and approves product and equipment specification such as User, Functional and Design Requirements.
Reviews and approves change control activities associated with R&D design, processes and equipment changes.
Provide Risk Management strategy for the design and development of new products to meet regulatory requirements.
Engages in a proactive approach to fault finding and troubleshooting, and identifying process improvements.
Identifies compliance risks during the product development cycle.
BS preferably in Engineering or Related Sciences.
MS in Engineering is preferred.
ASQ CQE, Six Sigma Certified, Greenbelt, Blackbelt or Professional Engineer is preferred.
Six (6) years of experience in Quality or Manufacturing within the Medical Device industry.
Additional six (6) years in Quality Engineering.
Experience using engineering tools is required; such as statistical programs (Minitab), risk assessment (FMEA), experimental design (DOE) and process improvement (SPC).
Demonstrated ability to lead a team and provide technical and business guidance.
Excellent written and verbal communication skills.
Effectively communicates both up and down the organization and maintains a customer focus.
Excellent planning and prioritization skills with the ability to multi-task and adapt.
Ability to identify, define and resolve problems using a structured methodology such as KTA.
Previous experience with Ministry of Health (MOH) inspections and responses.
Allergan, Inc. - 13 months ago
Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and...