Posted in Other 13 days ago.
Expected Travel: Up to 10%
Requisition ID: 5973
About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of identifying unmet clinical needs - to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
The Blood Products Quality Assurance (QA) Manager is responsible for overseeing a team that maintains quality processes and systems. The QA Manager has a strong understanding of GMP regulations and remains current on industry trends to ensure processes and systems are aligned. The QA team will maintain the Quality System, which includes Document and Record Management,Training Program, Change Management Program, Non-Conformance Events Program, Corrective Action/Preventative Action Program, Complaint Monitoring Program,Supplier Management Program, Annual Product Reviews, Regulatory Agency Requirements, and Management Review
• Ensure the optimal organizational structure, staffing, training and expertise levels exist to support business requirements on an ongoing basis.
• Remain current and thoroughly knowledgeable relative to the specifications, standards, and industry trends related to cGMPs to ensure that processes and systems are maintained in compliance with applicable regulatory requirements.
• Independently perform quality review and approval of Blood Product documents, such as Policies, Standard Operating Procedures, Work Instructions, Procedures, Plans, Study Protocols/Reports, Specifications and Forms.
• Independently perform quality review and approve change orders, investigations, non-conforming events, CAPAs and other associated activities.
• Provide direct oversight for document management, product disposition, material notifications, complaint investigations, Biological Product Deviation Reports and/or Recalls.
• Provide direct oversight for Blood Products Quality Management System Training program, Supplier Management program, and Annual Product Reviews.
• Provide direct oversight for evaluating and trending Blood Product QMS activities/programs for Management Review.
• Create and revise QMS procedures as needed.
• Identify and implement changes to the Blood Products Quality programs to improve effectiveness and efficiency.
• Proactively identify risks to the organization. Clearly and concisely communicate risks and mitigation opportunities, strategies and costs to senior management.
• Provide metrics and data driven solutions to reduce cost of quality and improve monitoring system efficiency for blood products.
• Monitor all production and laboratory operations to ensure compliance to cGMPs and Blood Product procedures
• Assist with Regulatory and/or other third party inspections.
Education / Experience Requirements
• Bachelor's Degree preferred
• 10+ years of relevant experience required
Specialized Skills / Other Requirements
• Proficiency with MS Office programs
• Good organizational skills and troubleshooting skills required
• Ability to coach others and provide functional management to junior engineering staff
• Strong understanding of Combination Products, Pharmaceutical, and Biologics cGMPs (21 CFR Parts 3.2(e), 4, 210-211, and 600-640)
• Strong understanding of FDA Guidances for Industry
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.
Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2021 Teleflex Incorporated. All rights reserved.
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