Sr. Quality Assurance Manager - Vascular 9/19/2017
JOB DESCRIPTIONAPPLY Opportunity:
Manage the Vascular Quality Assurance function to ensure product quality, conformance to engineering specifications and compliance to the quality system and regulatory requirements. Manage all department activities related to Quality Assurance, serve as business unit management representative, and act as liaison to Operations Management and Executive Level Business Unit Management.
The Corporate division is the central operating unit of the company setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. Company headquarters are located just outside of Philadelphia in Wayne, PA.
Serve as Vascular management representative per 21 CFR Part 820 and ISO 13485, ensuring that a quality system is established, implemented, and maintained in accordance with appropriate standards and/or regulations, reporting on the performance of the quality system to executive and top management.
Manage Quality Systems personnel to ensure goals are set and achieved.
Lead business unit in data collection and analysis. Define methods and support analysis including risk assessments, Health Hazard Evaluations, and support harmonization activities.
Manage the escalation and compilation of information necessary for executive management to assess if field actions/corrections and removals associated with Teleflex products is warranted.
Collect, summarize and evaluate data for management review meetings and to identify program weaknesses and make improvements in procedures or oversight of the program.
Direct facility personnel in quality-related technical principles, including but not limited to Problem Solving (Root Cause Analysis, DOE, FMEA, etc.) and Statistical Process Control.
Manage the quality system by collecting and analyzing data of the key processes.
Establish business unit level quality objectives; create quality planning documentation when necessary.
Manage key aspects of the Quality System, including but not limited to Management Reviews and QSRB meetings.
Participate in Business Unit related mergers and acquisitions providing due diligence and Quality support.
Support the implementation of product revisions and new product development.
Provide other department support as requested by immediate supervisor or Plant Manager.
Confer with engineering, manufacturing, customer service and sales personnel to resolve problems of product design, specifications, materials, tooling and production operations affecting quality.
Audit the facilities for conformances with applicable regulatory standards.
Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
EDUCATION / EXPERIENCE REQUIREMENTS:
Bachelor of Arts or Sciences degree in a technical, engineering, medical or science discipline.
Minimum 5 years experience in the medical device industry in quality assurance/quality engineering functions commensurate with the responsibilities outlined above.
Minimum 3 years managing quality assurance/quality engineering resources.
Extensive knowledge and understanding of US and European medical device regulations.
Extensive knowledge and understanding of US and International medical device standards and guidance documents including FDA, ISO, PMDA, MDD and CMDR.
SPECIALIZED SKILLS & OTHER REQUIREMENTS:
Experience and knowledge of lean manufacturing, six sigma and cost of quality tools and techniques
Experience and knowledge of design of experiments and other failure investigation methods
Experience with regulatory inspections/audits, specifically FDA and ISO inspectors
Experience performing internal and external audits
Knowledge and experience with corrective and preventive actions systems
Knowledge and experience with statistical process control, defects-per-million, and other process monitoring methods and techniques
Experience with Internet Applications, Agile and SAP preferred.
Experience with applied problem solving techniques preferred.
TRAVEL REQUIRED: 20 %
Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery. We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety.
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.