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Senior Project Engineer - Risk Management

Allergan, Inc.

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Location: Santa Barbara, CA Posted Date: 4/24/2013 Position Type: Full time Job Code: 130720 Required Education: High school or equivalent

Description

Execute risk management program for Allergan Medical (Breast Aesthetics) in Santa Barbara.  Develops and maintains risk management guidelines, procedures, and templates.  Ensure all risk management activities are in compliance with ISO 1497.  Conduct risk management training for engineers and staff.  

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

30%    Provide oversight of risk management program associated with design and development, technology transfer, validations, CAPAs, complaints, and deviations.  
10%    Utilize Design for Six Sigma methodology/tools to promote a disciplined approach to risk management in order to ensure product quality and process capabilities are maintained.
10%    Review and/or approve product and equipment specification such as User, Functional and Design Requirements to ensure appropriate risk assessments were performed.
10%    Review and approve change control activities associated with risk management processes/systems.  
10%    Provide Risk Management strategy for the design and development of new products to meet regulatory requirements.
10%    Engage in a proactive approach to fault finding and troubleshooting, and identifying process improvements.
10%    Ensure annual risk assessments and updates to the risk files are performed.
5%      Coach and mentor program/project team members in the proper interpretation and application of quality system/risk management processes and procedures.
5%      Prepare and present risk management program information to management.


This position has a solid line reporting relationship to Sr. Manager,  Sustaining 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/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, 6S housekeeping, cGMP procedures, general business policies, requirements and objectives. Must be willing to take temporary assignments as required.

Requirements

Bachelor degree in Engineering.
ASQ CQE, Six Sigma Certified, Greenbelt, Blackbelt or Professional Engineer is preferred.
Five (5) years of experience in Risk Management.
Six (6) years of experience in Quality or Manufacturing within the Medical Device industry.
Additional three (3) years of applied experience in Quality Engineering.
Experience in using statistical programs (Minitab) or engineering tools such as risk assessment (FMEA, FTA), experimental design (DOE), and process improvements (SPC) 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.
Previous experience with Ministry of Health (MOH) inspections and responses.
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