Senior Manufacturing Manager (Design Control System Improvement)

Location: East Walpole, MA
Job Type: Direct Hire
Salary: $1.00 - $1.00
Degree: Bachelor of Science;
Date: 6/14/2018
Job ID: 02604622
Job Description
Senior Manufacturing Manager (Design Control System Improvement)
East Walpole, MA
Competitive pay, Bonus, Excellent benefits
This role is with a global leader in medical technology (imaging, diagnostics, healthcare IT), an organization dedicated to ongoing success by hiring top talent, investing in R&D, and commitment to engineering excellence for over 100+ years. 
We currently have an opening for a Senior Manufacturing Manager. This role is focused on Control System Improvements; Design Quality Systems, developing standardization strategies and developing standards (Anchor, Gold, MDPs) where they may not exist. This is a role to take a mature business and division, to another level of excellence. You will surround yourself with process-driven, focused, professional people, developing top notch, high quality, quick-to-market life-changing products. 
Additional responsibilities
•           This role will focus on modifying the value process to align with new control system requirements. You will help create new protocols, data analysis, and compile reports/documentation. The facility is working with biological fluids (healthcare industry). The focus will be on-time completion of schedules and deliverables.
•           Manage Control System Improvement employees & facilitate cross-functional communication and collaboration across the organization in order to identify opportunities and eliminate obstacles.
•           Tactical and strategically plan ahead and identify challenges before they impact Control System Improvement deliverables.
•           Communicate status of issues/projects on a regular basis to all levels of the organization.
Desired Qualifications
•           Bachelor’s degree in Chemistry, Biology or Biological Science or similar
•           8-20+ years working in a manufacturing environment (medical, assay, or similar); with knowledge of assay architecture/design. 
•           Must have strengths in Design Control; including, Design Change, Process Change, Verification and Validation and Risk Management. 
•           Strong understanding of FDA and ISO regulations.
•           Demonstrated ability to analyze problems in a structured and systematic manner with the proven ability to interpret data and to troubleshoot and resolve technical issues.
•           Excellent quantitative skills and knowledge of statistics enabling the ability to work cross-functionally with statisticians.
•           Ability to multi-task and to support multiple project teams in cross-functional settings.
•           Excellent organizational, oral and written communication skills.
•           Ability to write clear and concise plans and reports and other quality documents.
•           A natural ability to manage and develop a diverse team with varying skill sets.
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