Expected Travel: Up to 50% 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 . 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 Supervise and manage the development and maintenance of all plant quality systems including supplier development, calibration, internal auditing, CAPA, quality engineering, production support efforts including validation/testing in the Mansfield, MA and Coventry, CT facilities. Manage OEM complaint handling. Establish and implement compliance training programs. Ensure that necessary regulatory corporate compliance systems are in place and adhered to. Represent quality for new product development and provide statistical support as needed throughout the plant. This position serves as the Management Representative for the Mansfield, MA and Coventry, CT facilities. Position is based in Mansfield, MA. Principal Responsibilities Management and development of staff in two facilities; ensure that CAPA, supplier/internal audits, calibration system, supplier development engineering, quality engineering, and complaint handling are staffed with qualified employees; ensure that direct reports are appropriately trained and have resources to do their assigned tasks; provide reports with career development opportunity Develop quality systems and establish procedures in compliance to FDA regulations and ISO requirements Work on assigned projects with limited supervision Represent Quality for new and existing product improvement, manufacturing transfers, and quality plan initiatives. Support protocol, procedure and specification development Complete special assignments as assigned by the Director of QARA Generally operate with appreciable latitude for actions or decisions on day-to-day activities; receive guidance on novel or controversial problems Outline and implement improvements to Quality System, and processes Education / Experience Requirements B.S. Degree in Engineering, Physical Science or similar. Masters Degree or MBA preferred. Minimum of 3 years medical device industry experience Minimum of 3 years related quality experience in a manufacturing environment Minimum of 2 years experience supervisory or management experience ASQ CQA or CQE certification preferred Broad engineering experience in manufacturing operations including new product development, cost reduction, and quality engineering Knowledge in textiles, clean room controls, medical device development and device assembly desirable Specialized Skills / Other Requirements Strong leadership and management skills Demonstrated experience in mentoring and coaching others Regulatory, cGMP, QSR, knowledge base Statistical knowledge (DOE, SPC, hypothesis testing, sample comparison) Strong computer skills (i.e. data-base development, statistical software and analysis, word processing for report generation, etc.) Strong negotiation and problem solving skills Ability to operate and communicate effectively with multiple teams Supplier auditing knowledge and ability (i.e. ASQ-CQA, internal/external courses, seminars) Able to understand blue prints, tolerance analysis and related knowledge Strong reasoning/analytical skills including the ability to, support and prioritize projects and adapt to shifting priorities Work with minimal supervision Able to successfully resolve problems and conflicts Travel Required Up to 40% (Travel consists primarily of driving between 2 company locations in MA and CT) 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. #J-18808-Ljbffr