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The Associate Quality Engineer shall support the Jaffrey, NH facility, Value Stream teams and Quality Assurance department in the development, implementation, and maintenance of the quality system, in order to maintain compliance to FDA 21CFR Part 820, ISO 13485 and Teleflex Global and Local procedures.
This position will also provide quality engineering support to manufacturing, engineering, and customer service with activities associated with manufacturing issues and improvement efforts; new product development; process validations and customer complaints.
Teleflex Medical OEM is the leading provider of comprehensive product development and production services to medical device manufacturers across the world. We set ourselves apart with deep expertise, decades of experience, and extensive, in-house capabilities, which include engineering, regulatory affairs, design for manufacturability, prototyping and validation, manufacturing, assembly and packaging. Our customers depend on Teleflex Medical OEM to deliver industry-changing innovations and next-generation solutions for precision extrusions, diagnostic and interventional catheters, sheath/dilator sets (introducers), medical balloons, specialty sutures and fibers, and bioresorbable sutures, yarns, and resins.
The primary responsibilities and duties will begin in a support role to the QE-Value stream team and laster shift to lead role within the VST, as appropriate skills and experiences are attained. • Assist QE and VST in execution of daily Quality Assurance activities associated with a designated manufacturing operation. Assist with quality and productivity improvement efforts when identified. • Assist with non-conformance (product or process) process including immediate actions, containment, root cause investigation; corrective action and disposition of nonconforming materials during Material Review Board (MRB) meetings. • Assist with Corrective and Preventive Action (CAPA) program. This includes leading or supporting a CAPA through each phase of process - Root Cause investigation; corrective action planning; corrective action implementation; verification of effectiveness (VOE) planning; VOE completion and CAPA closure. • Support the Customer Complaint process through primary investigation activities; inspection of complaint samples; review of manufacturing and inspection documentation; and development of corrective actions on confirmed complaints. • Support the Quality System through development and revision of procedures, inspection plans, test methods and work instructions. Become thoroughly knowledgeable relative to the specifications, standards, and required quality processes in the assigned area. • Participate in Internal Process audits and support external customer or Notified Body audits, as needed. Support and participate in Supplier audits as needed. • Work closely with manufacturing to support process operations and testing requirements. • Work closely with new product development engineers and supports protocol, procedure, and specification development. Implement test methodologies. Assist with completion of process validations or test method validations. • Develops, maintains and approves Inspection Procedures and Test Methods and provides training as required. • Assist QE with handling and resolving supplier quality issues (nonconformances and Supplier Corrective Actions). • Perform other QA duties as assigned by QE-VST or Quality Manager.
EDUCATION / EXPERIENCE REQUIREMENTS:
•Bachelor's degree in engineering, chemistry, physical science or related field is preferred or 3+ years of Quality Assurance experience working in medical device manufacturing environment. •Previous experience in generation and revision of Standard Operating Procedures (SOPs) for various quality and manufacturing related processes.
SPECIALIZED SKILLS & OTHER REQUIREMENTS: •Knowledge of QSR, ISO or CFR standards and regulations. (Required) •Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required. Experience with Minitab and SAP ERP is desired. •Problem solving skills and experience with Root Cause Analysis tools (6M, Cause-Effect, 5Ws etc) •Excellent listening, verbal and written communication skills •Previous experience with NC and CAPAs is required. Experience with customer complaint investigations is desired. •Excellent decision making, time management and reasoning ability •Excellent interpersonal skills with a demonstrated ability to work in a team •Ability to prioritize and adapt to shifting priorities •Ability to work with minimal supervision •Statistical skills desired (e.g., DOE, SPC, Gage R&R).
TRAVEL REQUIRED: <5%
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.
is an affirmative action & equal opportunity employer. D/V/M/F