Quality Manager - (US-MA-Framingham - 01705)

Minimum Education: None
Jobcode: L:98415252
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The Quality Manager will be responsible for managing and maintaining the corporate quality systems for the Company. This candidate will develop and maintain the procedures that define the processes related to Management Review, Quality Planning, data reporting tools and develop and support training for these areas worldwide. Additionally, the Quality Manager will maintain assigned aspects of the Corporate Quality System in compliance with all relevant regulatory requirements as well as ensure that the Corporation maintains certification to ISO 13485 and Medical Device Directive Requirements.

Duties and Responsibilities:
Creates and champions improvement in quality systems with specific emphasis on the Management Review, Quality Planning and data reporting processes.
Manages and facilitates the process for incorporating new and updated standards into the quality system.
Writes and/or oversees the development of the relevant quality system SOPs.
Lead continuous improvement and advancements for the department specifically related to the response to Field Actions.
Develops, implements, and complies with process metrics.
Coaches and mentors employees under direct supervisory responsibility, as well as influencing other team members not in the direct reporting line
Ensure implementation of Management Review, Quality Planning and data reporting processes and other functional excellence initiatives in Quality.
Utilize the Corporate CAPA system
Encourage problem-solving processes leading to solutions with leveragability in other parts of the company, particularly Six Sigma methodologies
Facilitate sharing of initiatives/ideas and accomplishments across divisions and functions. Remain current on all quality systems regulations for all regulatory agencies.
 
Minimum Education & Experience:
The ideal candidate will have Bachelor’s degree in a related field plus a minimum of 7 years experience in Quality or Operations environments or equivalent, with a minimum of 3 years experience managing staff.
Specific experience in Quality project management is highly desired.
Good oral and written communication and interpersonal skills required.
Experience with Six Sigma problem solving methodologies highly desired.
Proficient with Microsoft Office Suite required.
Self starter with strong, proactive work ethic.
Effective coach and mentor of less experienced staff.
Ability to collaborate well with cross-functional colleagues especially in R&D, Operations, Human Resources and Regulatory.