Quality Manager II, Product Inquiry 22799

Biotechnology and Pharmaceutical Quality Manager II, Product Inquiry 22799 Job Description:Manages and maintains the corporate quality systems across all relevant functions within Boston Scientific specifically in this role the manufacturing and distribution sites. The candidate is primarily responsible for managing the field action processes worldwide and provides expertise to the Quality Business Process Leads, Field Action Team Leaders and regional Field Action teams as needed. This candidate will develop and maintain the procedures that define the processes related to PIR’s, field actions, SAP recall reporting tools and develop and support training for these areas worldwide. Additionally, this candidate will support the execution of field actions and the tracking of active field actions to assure compliance to procedures and to maintain regulatory compliance. This candidate will also work closely with the design assurance teams on defining PDP deliverables to reduce and eliminate field actions. Maintain assigned aspects of the Corporate Quality System in compliance with all relevant regulatory requirements. 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 Field Action process. ? 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? Develops and ensures budgets and schedules are met. ? Ensure implementation of Field Action processes and other functional excellence initiatives in Quality. ? Support the Corporate Management Review process, by tracking and providing metrics for measurements? 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.Job Experience:Minimum Education & Experience:Bachelor’s degree 7+ Years experience in Quality or Operations environments or equivalent, with a minimum of 3 years experience managing staff.Specific experience in complaint handling, post-market compliance or recall administration is highly desired.Working Conditions:General office environment with 30%+ travel to BSC sites experiencing field actions is mandatory.Competency Expectations:? Good oral and written communication and interpersonal skills required.? Experience with Six Sigma problem solving methodologies highly desired? Proficient with Microsoft Office Suite required, SAP experience preferred? 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 and RegulatoryMinimum Education Required: BachelorYears of Experience Required: More than 5 yearsExpected Travel Time: NoneThis company may offer relocation assistance. Please visit us online at www.bostonscientific.com for more information.