About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
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.
Quality leader to drive BU and Internal programs, systems development and improvement activities relating to the operation of the Quality Management System.
Key responsibilities will include (but are not limited) to the following
- Develop quality systems and establish procedures in compliance to FDA regulations and ISO requirements
- Manage, support and monitor the CAPA process.
- Lead, drive and monitor effectiveness of the Internal audit process
- Manage and host, Customer and regulatory audits.
- Site project leader for the OEM business QMS projects as required.
- Site system owner of Electronic QMS, maintain current, validated and configured to meet business needs
- Site quality technical lead for software approval / Information System projects as required.
- Preparation of monthly and management review data metrics on Quality System and Quality performance e.g. Complaints, NC’s, CAPA, Audits, supplier performance etc.
- Designate Management Representative in the absence of the Quality Manager, as required.
- Establish and implement Quality compliance programs.
- Drive performance and process improvements across the Quality Management System and takes initiatives to make things better every day.
- Lead, motivate and develop self and team to meet performance and growth objectives.
- Develop and cascade departmental long term and short-term business objectives, in line with business needs.
- Lead, motivate and mentor cross functional teams to ensure that project milestones and results are achieved in line with business needs.
- Works with other departments to facilitate professional and timely delivery of information relating to quality, regulatory, Customer and other queries as they arise.
- Monitor and drive compliance to GMP and the requirements of the QMS
- Drive quality system improvement projects as directed
- Ensure full compliance with regulatory requirements.
- Ensure Quality and EHS policies and procedures are always adhered to.
- Degree in Engineering/ Quality, Life Sciences, or a related business technical field essential.
- Min 5 Years’ experience in Quality Systems Management in the FDA 21 CFR 820, ISO 13485, regulated Medical Device /Component Industry.
- Certified QE, desirable
- Technical report writing skill
- Strong negotiation and problem-solving skills
- Auditing knowledge and ability (i.e. Lead assessor certified desirable)
- Strong reasoning/analytical skills including the ability to, support and prioritize projects and adapt to shifting priorities
- Working knowledge of Risk Management and validation principles, in particular software validation GAMP5
- Previous experience of Managing project teams desirable.
- Planning and Organisation skills – Project and programme oversight, sponsorship and management
People
- Performance Management of others
- Coaching and mentoring
- Employee Development
- Excellent Written and Verbal Communications.
- A positive attitude in dealing with people.
- Proven ability to lead and give direction to team members on all aspects of Quality Systems
- Ability to lead meetings
- Ability to operate and communicate effectively with multiple teams
- Display High levels of emotional intelligence
- Display Qualities and Principles of Genuine Leadership
- Work with minimal supervision
- Able to successfully resolve problems and conflicts
Customer and Vendors
- Ability to generate appropriate relationships with customers, regulators, and leadership.
- Ability to deal with difficult customer communications
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Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community. If you require accommodation to apply for a position, please contact us at [email protected].
Diversity fosters innovative thinking and entrepreneurship and that’s what we are about at Teleflex. We trust and value our people and their diversity and we make it fun to work here. We are on a journey to ensure our workplaces mirror the patients we serve and the communities we operate in.Our approach is simple, we embrace everyone and want them to feel they belong here.We are building a culture where all employees can bring their best and unique selves to work.If that appeals to you, we would love to hear from you. Come join a company where diversity is sought out and inclusivity is how we progress.
At Teleflex, we follow 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, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
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