Teleflex
Teleflex – OEM Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
Position Summary
This position provides Quality Engineering leadership to Conductor manufacturing as the lead Quality member on the team. The primary purposes and objectives include: Nonconformance and CAPA coordination and processing; Customer complaint investigations; Process & product validations; Customer Notification of Change evaluations; Internal & external auditing responsibilities and support; Quality improvement projects; and Maintain compliance with applicable Teleflex Global & local Procedures and Policies Nonconformance (NC) and CAPA processing – lead quality activities with respect to Conductor Material Review Board coordination; inspection methods, NC containment/correction/closure and CAPAs; and drive improvement through analysis of trend data. Customer Complaint Investigations – Primary investigator and facilitator for Conductor complaint investigation, confirmation and corrective actions. Act as primary customer contact on complaint communications. Drive improvement based on trends. Process Validations – guide and review protocol development, validation implementation and report review and acceptance; Quality & Cost Improvement Projects – lead and participate on key short-term projects on product or process improvements; Production & Process Controls – review, change and approve Manufacturing Procedures; Test Method validations; Quality Inspection Plans and Process run sheets Auditing – routinely perform internal and process-related audits. Participate in vendor audits if necessary. Support the Back Room during FDA and Notified Body audits. Documentation Control – perform Customer Product Specification reviews. Initiate Engineering Change Notices and review/approve as needed. Training – Perform QA training certifications on new Production operators. Support Engineering with improving Product with quality planning, risk evaluation and validation. Perform any additional QA tasks, as assigned by QA Manager. Education / Experience Requirements
Excellent communication and presentation skills. Bachelor degree is preferred or the equivalent ASQ Certified Quality Engineer certification. 3+ years of Quality Assurance experience required. Experience in a manufacturing environment, with preference in a regulated or medical industry. CAPA and Nonconformance process Customer Complaint Investigations Validation concepts & techniques (process, equipment, and test methods) Continuous Improvement Process/Project Management Process or internal auditing. • Additional experience with the following areas is desired: DOE, SPC, Gage R&R, Minitab, SAP ERP, statistical techniques, root cause analysis tools (6M, cause-effect, 5 Whys), and design control and risk management experience. Specialized Skills / Other Requirements
Knowledge of QSR, CFR, cGMP, and ISO regulations (required) Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint Experience with Minitab and SAP ERP is desired Statistical Techniques desired (DOE, SPC, Gage R&R) Problem solving skills and experience with Root Cause Analysis tools (6M, Cause-Effect, 5Ws etc) Good listening, verbal and written communication skills Excellent interpersonal skills with a demonstrated ability to work in a team environment Ability to prioritize and adapt to shifting priorities is desired Ability to work independently with limited supervision ASQ Certified Quality Auditor highly desired Design Control and Risk Management experience desired #LI-EB1 Working Conditions / Physical Demands
TRAVEL REQUIRED: 10% Teleflex follows a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front. Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
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This position provides Quality Engineering leadership to Conductor manufacturing as the lead Quality member on the team. The primary purposes and objectives include: Nonconformance and CAPA coordination and processing; Customer complaint investigations; Process & product validations; Customer Notification of Change evaluations; Internal & external auditing responsibilities and support; Quality improvement projects; and Maintain compliance with applicable Teleflex Global & local Procedures and Policies Nonconformance (NC) and CAPA processing – lead quality activities with respect to Conductor Material Review Board coordination; inspection methods, NC containment/correction/closure and CAPAs; and drive improvement through analysis of trend data. Customer Complaint Investigations – Primary investigator and facilitator for Conductor complaint investigation, confirmation and corrective actions. Act as primary customer contact on complaint communications. Drive improvement based on trends. Process Validations – guide and review protocol development, validation implementation and report review and acceptance; Quality & Cost Improvement Projects – lead and participate on key short-term projects on product or process improvements; Production & Process Controls – review, change and approve Manufacturing Procedures; Test Method validations; Quality Inspection Plans and Process run sheets Auditing – routinely perform internal and process-related audits. Participate in vendor audits if necessary. Support the Back Room during FDA and Notified Body audits. Documentation Control – perform Customer Product Specification reviews. Initiate Engineering Change Notices and review/approve as needed. Training – Perform QA training certifications on new Production operators. Support Engineering with improving Product with quality planning, risk evaluation and validation. Perform any additional QA tasks, as assigned by QA Manager. Education / Experience Requirements
Excellent communication and presentation skills. Bachelor degree is preferred or the equivalent ASQ Certified Quality Engineer certification. 3+ years of Quality Assurance experience required. Experience in a manufacturing environment, with preference in a regulated or medical industry. CAPA and Nonconformance process Customer Complaint Investigations Validation concepts & techniques (process, equipment, and test methods) Continuous Improvement Process/Project Management Process or internal auditing. • Additional experience with the following areas is desired: DOE, SPC, Gage R&R, Minitab, SAP ERP, statistical techniques, root cause analysis tools (6M, cause-effect, 5 Whys), and design control and risk management experience. Specialized Skills / Other Requirements
Knowledge of QSR, CFR, cGMP, and ISO regulations (required) Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint Experience with Minitab and SAP ERP is desired Statistical Techniques desired (DOE, SPC, Gage R&R) Problem solving skills and experience with Root Cause Analysis tools (6M, Cause-Effect, 5Ws etc) Good listening, verbal and written communication skills Excellent interpersonal skills with a demonstrated ability to work in a team environment Ability to prioritize and adapt to shifting priorities is desired Ability to work independently with limited supervision ASQ Certified Quality Auditor highly desired Design Control and Risk Management experience desired #LI-EB1 Working Conditions / Physical Demands
TRAVEL REQUIRED: 10% Teleflex follows a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front. Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
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