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Km80.5

Senior Quality Engineer

Allergan, Inc.

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Location: Santa Barbara, CA Posted Date: 4/24/2013 Position Type: Full time Job Code: 130740 Required Education: High school or equivalent

Description

Provides oversight of design control activities, design and technology transfer to manufacturing, risk management program and process validation activities for Allergan Medical (Breast Aesthetics) in Santa Barbara, CA.  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.

This position has full responsibility and accountability to act and make decisions in the respective job duties.  

30%    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.
10%    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.
10%    Reviews and approves product and equipment specification such as User, Functional and Design Requirements.
10%    Reviews and approves change control activities associated with R&D design, processes and equipment changes.  
10%    Provide Risk Management strategy for the design and development of new products to meet regulatory requirements.
10%    Engages in a proactive approach to fault finding and troubleshooting, and identifying process improvements.
10%    Identifies compliance risks during the product development cycle.
5%      Coaches and mentors program/project team members in the proper interpretation and application of quality system processes and procedure.
5%      Prepares and presents technical and PDP program/project information to management.

This position has a solid line reporting relationship to Manager, Quality Engineering.

Allergan is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, EMEA, ISO 13485:2003/CMDCAS, Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, EEOC, and ADA.

Incumbent has full authority to make decisions and/or take action that is required to carry out job duties.  Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, 5S housekeeping, cGMP procedures, general business policies, requirements and objectives. Must be willing to take temporary assignments as required.

Requirements

BS in Engineering.
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, Aviation or Automotive industries.
Additional six (6) years in Quality Engineering.
Experience using statistical programs like Minitab, risk assessment (FMEA), experimental design (DOE) and process improvement (SPC) tools is required.
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.
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