Senior Corporate Risk Management Quality Engineer
Framingham, MA
Special referral bonus for this job:
$500 Bonus Offered
Job Summary:
In this role, you will play a key staff role in drafting a new Risk Management systems strategy (and subsequent execution of that strategy) for a major medical device manufacturer.
Key Responsibilities:
• Ensures that contributions maximize Risk Management systems compliance to regulatory requirements, as well as drive efficiency and excellence in product development and commercialization environments.
• Provides guidance and approval (as applicable) regarding risk management strategies and approaches.
• Assists in communication of Risk Management team objectives, goals, and subsequent conclusions with (at a minimum) their home function. Communication responsibilities may extend out to include other business units, divisions, etc. depending on how individual is assigned to a role on the final team.
• Maintains and enhances cross-functional team relationships. This will include working with other Project Horizon teams to insure a real-time communication of issues as related to Risk Management.
• Work with quality system owners/stewards on strengthening the connection of Risk Management to their element(s) of the quality system
• Works cross-functionally in identifying and resolving technical issues including modeling activities for the core and/or integrated systems, using project/site/quality system data to ensure effectiveness of the Risk Management system prior to global roll out.
• Monitors and evaluates project progress and results as assigned.
• Provide coaching to other functional groups on elements of Risk Management activities
Preferred Qualifications include:
• 6+ years and/or equivalent medical device industrial experience, with heavy emphasis on usage of Risk Management toolbox (ex: FMEA, FTA, and other Risk Management & Analysis tools.)
• Basic experience with risk management planning and reporting per ISO 14971
• Proficient, working understanding of primary external regulatory guidance documents around Risk Management (ex: ISO 14971)
• Strong systems engineering background – either through educational experience, industrial experience, or both. Examples of systems engineering might come from systems architecture training, product development using a formalized stage gate or iterative process, process mapping training, etc.
• Excellent communication skills – must have experience creating PowerPoint presentations and speaking in front of large groups of people.
In this role, you will play a key staff role in drafting a new Risk Management systems strategy (and subsequent execution of that strategy) for a major medical device manufacturer.
Key Responsibilities:
• Ensures that contributions maximize Risk Management systems compliance to regulatory requirements, as well as drive efficiency and excellence in product development and commercialization environments.
• Provides guidance and approval (as applicable) regarding risk management strategies and approaches.
• Assists in communication of Risk Management team objectives, goals, and subsequent conclusions with (at a minimum) their home function. Communication responsibilities may extend out to include other business units, divisions, etc. depending on how individual is assigned to a role on the final team.
• Maintains and enhances cross-functional team relationships. This will include working with other Project Horizon teams to insure a real-time communication of issues as related to Risk Management.
• Work with quality system owners/stewards on strengthening the connection of Risk Management to their element(s) of the quality system
• Works cross-functionally in identifying and resolving technical issues including modeling activities for the core and/or integrated systems, using project/site/quality system data to ensure effectiveness of the Risk Management system prior to global roll out.
• Monitors and evaluates project progress and results as assigned.
• Provide coaching to other functional groups on elements of Risk Management activities
Preferred Qualifications include:
• 6+ years and/or equivalent medical device industrial experience, with heavy emphasis on usage of Risk Management toolbox (ex: FMEA, FTA, and other Risk Management & Analysis tools.)
• Basic experience with risk management planning and reporting per ISO 14971
• Proficient, working understanding of primary external regulatory guidance documents around Risk Management (ex: ISO 14971)
• Strong systems engineering background – either through educational experience, industrial experience, or both. Examples of systems engineering might come from systems architecture training, product development using a formalized stage gate or iterative process, process mapping training, etc.
• Excellent communication skills – must have experience creating PowerPoint presentations and speaking in front of large groups of people.
