Location(s): United States; Massachusetts; Westborough
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Role Summary: The role will support cross-functional/multi-disciplinary projects in order to create a more scalable, high quality global Healthcare BP Services platform in fulfillment of FlexFactory. This role achieves quality objectives by contributing information and analysis to strategic project plans and reviews.
Essential Responsibilities: This role may be delegated as a quality control function; navigates thru and implements practical implementation of the quality system for this newer business segment. Assures consistent quality of production by developing and enforcing good automated practice (GAMP) system.
Operations: • Simplify and/or mitigate processes that prevent the business from meeting the expectations of the customers and the business at large •Lead quality operational objectives by gathering and contributing information and analysis to strategic plans and reviews; identifying and resolving problems; determining system improvements; implementing change. •Identify critical control points and preventive measures; establishing critical quality limits, monitoring procedures, corrective actions, and verification procedures. •Assessment of Quality processes regarding Manufacturing releases •Address critical, real-time issues that arise during MFG process •Anticipate events that impact customer deliverables •Streamline the Quality process for on-time Flex Factory deliveries Process Improvements: • Learn, Identify and Lean areas within MFG process that could lead to process improvements • Drive towards real-time mitigation of Quality operations
Essential Functions: • Manage, oversee and train quality functions within Enterprise • Support FF review and release activities for completion of Enterprise milestone • Assign FF projects to quality functions within Enterprise for review and release activities • Review and approve quality procedures, work instructions and functional test documents as needed • Interpret and implement quality standards • Review and approve executed protocols • identify training needs and organize training interventions to meet quality standards • support on-site audits conducted by external providers • evaluate audit findings and drive to implement appropriate corrective actions • monitor risk management activities • assure ongoing compliance with quality and industry regulatory requirements • assist in the completion of vendor audit questionnaires •Function as an information source for other departments when critical quality issues arise.
Direct Responsibility: • Design review and approval for Automation Hardware • Review and approval of Functional testing for Automation Hardware • Review and approval of Configuration protocols and reports • Review and approval of Customizations Verification protocols and reports • Review and approval of Integration protocols and reports • Review and approval of Documentation for Hardware and Automation • Release of FlexFactory product
Quality Specific Goals: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position 2. Complete all planned Quality & Compliance training within the defined deadlines 3. Identify and report any quality or compliance concerns and take immediate corrective action as required 4. Drive compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones 5. Identify continuous improvement activities by initiating the implementation of process and product quality improvement initiatives
Qualifications/Requirements: 1. Bachelors Degree within appropriate Engineering/Science discipline or Bachelors Degree and 2 years of cross-functional Project Leadership experience or equivalent (defined as High School Diploma/GED and 4 years progressive experience within the discipline. 2. Minimum of 5 years of experience in program management or project leadership within a manufacturing, development, technical industry or research environment 3. Demonstrated execution at meeting project goals while satisfying quality, performance, schedule, and budget CTQ’s 4. Demonstrated engineering knowledge, program management, and business planning processes, having experience with the full product lifecycle from concept through end of life 5. Familiarity with ISO, FDA and other regulatory standards
Desired Characteristics: 1. Demonstrated experience driving variable cost productivity (VCP) and Inventory Carrying Value (ICV) reduction to enable optimized product margins 2. Masters degree in Engineering or equivalent (defined as 12 years progressive experience within engineering, science, or related field, including 8 years project leadership experience within manufacturing, development, or research development) 3. Strategic planner and thinker with ability to drive change across the segment products 4. Sound technical and domain experience in at least one functional technology area 5. Demonstrated experience on global product releases throughout the entire NPI cycle 6. Strong written and oral communication skills 7. Excellent knowledge in engineering, program management and business planning processes having experience with the full product lifecycle 8. Self-starter, energizing, results oriented, and able to multi-task 9. Demonstrated problem solving ability and results orientation 10. Demonstrated LEAN skills
Locations: United States; Massachusetts; Westborough
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