Associate Director of Quality - Contract Manufacturing Medical Devices - See more at:

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Job ID Number: 2014010856 Location: USA - MA - Mansfield Job Description SUMMARY OF POSITION: The Associate Director of Quality – Contract Manufacturing Medical Devices is responsible for managing all finished goods Contract Manufacturing (CM) for the Medical Devices business. Primary duties are focused on all QMS related matters pertaining to selection, qualification, manufacturing, QMS development, and technical quality/service/costs improvements for all Medical Device CMs. This position will have a team of CM Quality Managers/Engineers representing each Franchise. ESSENTIAL FUNCTIONS: Develop a strategy to manage a global, cross-franchise group of CMs supporting the Medical Devices business Plan, organize, direct and report on all Medical Device CM quality-related activities Lead, manage, and mentor a team of CM Managers/Engineers who manage the specific CMs in each franchise Partner with C&RM team to develop an effective CM Quality process that supports finished goods product quality globally for all of Covidien Develop, implement, and monitor C&RM development initiatives, including CM performance management, CM certification, process improvements, cost reduction, supplier forums, Six Sigma/Lean integration, audits, and selectionactivities, that align with the Medical Devices strategic goals and objectives Ensure compliance with Covidien Quality Systems and all relevant internal procedures and policies Lead by Example: Setting continuous-improvement driven mentality and solid quality culture for the organization Represent the C&RM organization for all CM quality related reviews and discussions at the Medical Device and Franchise levels Cooperates with other top management personnel in formulating and establishing company policies, procedures, objectives and goals regarding Quality Assurance Maintain compliance to set Key Performance Indicators for Medical Devices Quality Communicate with the Medical Device Quality leadership on C&RM initiatives, updates, and issues Work with new and existing CMs to develop, implement, and maintain technical quality assurance systems and activities, to include MSAs, SPC, Quality Plans, Control Plans, and FMEAs Collaborate with the Medical Device Franchise NPD Supplier Quality and Design Quality teams to evaluate and understand future CMs and their associated quality and development plans Collaborate with the Medical Devices Franchises to insure proper complaints handling and investigations Partner with Regional C&RM Quality Managers to build a strategy for managing the CMs in all regions Maintain highest level of compliance and operational standards set by Medical Devices or Covidien Establish and drive cultural standards of Quality, Service, Safety, Performance and Teamwork Responsible for ensuring that effective up-to-date CM Quality Assurance documentation, procedures and specifications are maintained Drive standardization across all Medical Device Franchises for CM engagements Participate in annual supplier forums OTHER FUNCTIONS: Is the liaison between Medical Devices/Franchises and CM sites for the deployment and communication of needs and new or improved quality requirements Participates on and assists teams and sourcing in making key CM product decisions that affect product performance Ensures statistical process tools are used effectively to reduce waste and product variability MINIMUM REQUIREMENTS: Bachelor’s Degree in a scientific or technical field Six (6) years’ experience in the Drug/Medical Device industry with five (5) years Quality Assurance experience in the medical device or drug industry, including previous supervisory/management experience Demonstrated track record of effectively influencing and negotiating with all levels of an organization and leading effective/successful change initiatives Demonstrated knowledge and expertise in: supply chain management and supplier development, stakeholder management, risk/issue management, implementation planning, training/communication, scope management Thorough understanding of the US and international regulatory and quality assurance requirements associated with the development and manufacture of medical devices or drug products - (QSR) and ISO requirements Ability to prepare and execute effective presentations to leadership 6 Sigma and/or Lean experience preferred (trained or certified) Mastery of medical device quality systems and applications is required Demonstrated ability to work successfully in complex and emerging markets, leveraging interpersonal, communication, and technical skills to optimize results Self-starter, with the ability to work independently and with all levels of VPs, managers, associates, and clients Can effectively lead Change Management efforts Excellent oral/written communication skills Strong analytical and statistical problem solving tools Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab Ability to travel frequently, both domestically and internationally (50%) Base Location is Mansfield, MA or North Haven, CT - See more at:
Phama Job Categories: 
Quality Control

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