Suzanne Carpenter Email and Phone Number
5 Basel Street, Petach Tikva, 49131, il
Suzanne Carpenter's Location
Park City, Utah, United States, United States
Suzanne Carpenter's Contact Details
Suzanne Carpenter work email
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- Valid
Suzanne Carpenter personal email
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Suzanne Carpenter phone numbers
About Suzanne Carpenter
High energy, dedicated, quality professional supporting work in the medical device industry.
Suzanne Carpenter's Current Company Details
Teva Pharmaceuticals
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Director of Quality Assurance for Teva Pharmaceuticals
5 Basel Street, Petach Tikva, 49131, il
- Website:
- tevapharm.com
- Employees:
- 10
Suzanne Carpenter Work Experience Details
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Director Of Quality AssuranceTeva Pharmaceuticals Mar 2022 - PresentSalt Lake City Metropolitan Area
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Associate Director, Quality Compliance Cmso SegmentTeva Pharmaceuticals Nov 2020 - Dec 2022Corporate ComplianceResponsible to support inspection readiness at US sites for Teva Pharmaceuticals in the CMSO segment. Develop recommendations in the area of combination products commercialization. Support regulatory inspections and responses within the CMSO network.
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Compliance ManagerTeva Pharmaceuticals Sep 2014 - Oct 2020Greater Salt Lake City AreaResponsible for cooridinating external regulatory agency inspections and responses. Leader for Internal audit, Supplier Audit, Annual Product Reporting for transdermal, topicals, and creams product line. This includes products manufactured in US and distributed world wide.
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Sr Director Of QualityEdwards Lifesciences Jul 2013 - Jul 2014Draper, UtResponsible for Quality activities in the areas of recall management, internal audit, receiving inspection, metrology, document control and CAPA. -
Sr Director Of QualityEdwards Lifesciences Apr 2011 - Jul 2013Responsible for Quality activities shared by three business units at the site including Microbiology, Chemistry, Metrology, Receiving Inspection, and Document Control. Responsible for all Quality activities for Cardiac Surgery Systems new products, supplier quality, production support and complaint investigation. This includes products manufactured in US and distributed world wide. Define and manage QA activities that include Training, Process improvement and Quality Metrics. 1. Interface with all areas of business to facilitate investigations, resource assignment, and CA/PA implementation. 2. Used Lean methodologies to improve the receiving inspection, microbiology, chemistry, and metrology processes for timely execution of tasks. This included building new work areas for each function. 3. Launched five new 510(k) approved products in 18 months. 4. Executed recalls and communicated recall status to the FDA. 5. Supported remediation of 27 design history files to meet EU Medical Device Directive and US FDA requirements. 6. Review changes in approval standards and design requirements to determine changes necessary to internal testing methods and documentation. 7. Lead Quality Management Reviews for CSS businesss.8. External audit site leader
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Director Of QualityEdwards Lifesciences Sep 2010 - Apr 2011Responsible for business unit support for new product development, production support, supplier management and complaints investigations.
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Sr. Manager Of QualityEdwards Lifesciences Sep 2009 - Sep 2010Responsible for Supplier Management, Complaints Management and Production support.
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Director Of QualityGe Healthcare Sep 2008 - Aug 2009Greater Salt Lake City AreaLead and manage the complaint handling, investigation and CA/PA group for GEHC Surgery. This includes products manufactured in US and distributed world wide. Ensure regulatory compliance and optimization of quality system procedures related to complaint handling. Support key RA/QA activities that include Training, Process improvement and Quality Metrics. Support Quality Management Reviews at P&L and GEHC levels. 1. Use ISO 14971 Risk Management for Medical Devices to evaluate results of complaint investigations to determine the priority of futher investigations. 2. Group complaints into technical categories for effective investigation and CA/PA determination.3. Interface with all areas of business to facilitate investigations, resource assignment, and CA/PA implementation. 4. Continuously improve the process for timely execution of tasks. 5. Create regular management presentations to review business metrics and improvement opportunities. -
Vp Of QualityViking Group Inc. May 1999 - Aug 2008Hastings, MiThe Vice President of Quality Systems is responsible for interfacing with all departments inside Viking Corporation to assess compliance to procedures and opportunities for continuous improvement. The Vice President also leads facility audits along with follow-up responses with International Approval Agencies and maintain quality relationship. The countries included are US, UK, Germany, Russia, China, Poland, and France. Procedures are established to maintain a system of compliance with design requirements and approval agency standards. Primary focus is to supervise and guide Quality Engineers and Technicians as they collect, review and respond to data in the course of manufacturing and testing. -
Director Of QualityMann+Hummel Group May 1994 - May 1999Kalamazoo, Michigan AreaFunctioned as Director of Quality responsible for interfacing with all departments inside Mann + Hummel to assess compliance to customer requirements and procedures for injection molded under hood plastics. Some of the specific responsibilities are listed below:1. Completed survey and approval process to obtain Ford Q1 in one year from start for plastic injection molding facility. 2. Revised Quality System from TFE to ISO 9001 to QS-9000. Completed QS-9000 registration process first pass. 3. Plan, organize and lead department of two managers, six engineers, four auditors, three technicians, and 14 inspectors for manufacturing support,engineering and advanced product planning support. 4. Participated as a team member of four directors who were responsible for completing company budget and business plan. Studied injection molding processes using statistical experimentation (DOE). 5. Responsible for training all employees on Statistical Process Control (SPC) and Team Problem Solving. 6. Established visitation process with automotive customers to build relationships and prevent the issuance of PRRs, QRs, and Referrals. 7. Implemented measurement and feedback system that reduced internal ppm by 50%. 8. Monitor and develop staff on Advanced Product Quality Planning (APQP) and Failure Mode and Effects Analysis (FMEA) methods in the completion of customer required documents. -
Quality Assurance ManagerPreferred Plastics Sep 1992 - May 1994Plainwell, MiOriginally hired to renovated a quality system to Q1 level in eleven months in an automotive plastics extrusion plant, with significant emphasis on Advanced Quality Planning. The facility was part of UTA and the Q1 status was on probation. 1. Began employee participation teams to reduce and eliminate historical quality problems. Team reduced scrap on process by 50% in two months. 2.Instituted a computerized Quality monitoring system for internal and external customer quality issues. Trained all employees on Team Problem Solving and Statistical Process Control (SPC). 3. Studied extrusion processes using design of experiments. 4. Directed and assisted with activities in materials lab doing PVC material tests and color matching. 5. Performed design of experiments to determine tolerance levels and vendor selection for pigments in custom color matched extruded products. 6. Assumed project engineering role on new projects for Chrysler and Ford due to large turnover in engineering and sales staff. -
Engineering ManagerSmiths Industries Nov 1989 - Sep 1992Greater Grand Rapids, Michigan AreaManaged eight engineers and three clerks responsible for product design, process design, and production support of circuit board assembly of avionics systems. Successfully transitioned group's responsibilities from purely floor support in a reactive mode to include design and process development engineering (Concurrent Engineering) in a proactive mode. Implemented training from Crosby Quality College into daily operations of group. Personally responsible for participating in new product proposals and quoting engineering and production labor hours to complete new circuit board assemblies. -
Manufacturing EngineerSmiths Industries Jun 1986 - Nov 1989Greater Grand Rapids, Michigan AreaImplemented Just-In-Time manufacturing techniques in avionics chassis assembly area, reduced assembly time by 42%. Investigated and implemented new process creation system that reduce engineering time by 33%, and reduced cycle time by 200%. During this same project created a direct link to the CAD system used by the design group. Developed training plan and taught SPC and problem solving to Manufacturing, Quality and Test Engineers. Performed design of experiments on wave soldering, surface mount soldering, and microcircuit wire bonding processes.
Suzanne Carpenter Skills
Quality System
Fda
Capa
Quality Assurance
Quality Management
Medical Devices
Spc
Iso 13485
Iso 14971
Complaint Management
Value Stream Mapping
Continuous Improvement
Supplier Quality
Fmea
Design Of Experiments
Management
Design Control
External Audit
Statistics
Lean Thinking
Creative Problem Solving
Resource Management
Auditing
U.s. Food And Drug Administration
Corrective And Preventive Action
Interpersonal Skill
Suzanne Carpenter Education Details
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Industrial Engineering
Frequently Asked Questions about Suzanne Carpenter
What company does Suzanne Carpenter work for?
Suzanne Carpenter works for Teva Pharmaceuticals
What is Suzanne Carpenter's role at the current company?
Suzanne Carpenter's current role is Director of Quality Assurance for Teva Pharmaceuticals.
What is Suzanne Carpenter's email address?
Suzanne Carpenter's email address is su****@****arm.com
What is Suzanne Carpenter's direct phone number?
Suzanne Carpenter's direct phone number is +126949*****
What schools did Suzanne Carpenter attend?
Suzanne Carpenter attended University Of Nebraska-Lincoln.
What skills is Suzanne Carpenter known for?
Suzanne Carpenter has skills like Quality System, Fda, Capa, Quality Assurance, Quality Management, Medical Devices, Spc, Iso 13485, Iso 14971, Complaint Management, Value Stream Mapping, Continuous Improvement.
Who are Suzanne Carpenter's colleagues?
Suzanne Carpenter's colleagues are Przemysław Kamiński, Maria Dioszegi, Hakkı Özdemir, Sunilkumar Thak, Peleg Ben-Efraim, Rocher Drevet Rachel, Harel Dorev.
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