Quality Engineer II

Position Summary

In accordance with quality control and quality assurance principles, and under limited supervision, the Quality Engineer II will be responsible for Teleflex’s Z-Medica portfolio of hemostatic medical devices and provide quality engineering services to an assigned area of more extensive scope and/or several sub-systems of the overall quality system. 
The incumbent will be competent in quality system fundamentals, details of specifications, and related quality standards in the assigned area ensuring all necessary systems are applied and effective. The Quality Engineer II will possess a significant understanding and application of statistical methods to product and process development. This position is accountable for a broad range of technical assignments in assigned quality engineering areas under limited supervision and may assist or review the work of quality inspectors.
 

Principal Responsibilities

•    Identify and lead site projects as agreed with management. Aid personnel as assigned. Reporting on status and progress as required. Responsible for oversite and performance quality subsystems or subgroups as assigned.
•    Knowledgeable relative to the specifications, standards, and required quality systems in assigned areas. Create/Write/Revise procedures and specifications as necessary. 
•    Work on assigned projects under limited supervision. Assist quality inspectors, contract resources, interns, etc. as required or directed by the Quality Manager. 
•    Competent in researching, writing, and performing Installation Qualification (IQ), Operation Qualification (OQ), and Process Qualification (PQ) validation protocols.
•    Knowledgeable in writing and maintaining various quality management systems. Track internal quality issues and report on corrective action progress, including performing failure investigations and making recommendations for corrective actions.
•    Support and evaluate testing and inspection methods to identify areas for improvement, efficiency, and cost reductions.
•    Partner with affiliated disciplines, (i.e., Regulatory Affairs, Quality Engineering, New Product Development, Operations, Supplier Management) to ensure that adequate design controls and/or procedures are complied with and met to facilitate design transfer activities.
•    Work closely with sustaining engineers and support protocol, procedure, and specification development.  Implement test methodologies.
•    Work closely with suppliers in process development. Use of statistical methods as appropriate.
•    Work closely with purchasing and supplier quality to ensure supplier controls are complied with and met per procedures.
•    Aid and participate in external and internal audits and complaint investigations. 
•    Maintain and improve mastery of technical information and knowledge as pertains to site products and projects through seminar attendance and/or professional certifications.  
•    Ability to read blueprints, drawings, and various technical documents relating to the site and its products.
 

Education / Experience Requirements

•    BS degree in engineering, life science, or related field.  MS preferred. 
•    Minimum of two years’ experience in the medical device field.
•    Broad experience in manufacturing operations, including new product development and implementation, process qualification, cost reduction, and quality engineering.
•    Six Sigma green belt preferred.
 

Specialized Skills / Other Requirements

•    Regulatory, cGMP, QSR, ISO 13485 & 14971 knowledge.
•    Proficient with Microsoft Office, including Word, Excel, and Outlook (i.e., database development, statistical software and analysis, simulation, word processing for report generation, etc.) Minitab experience is a plus.
•    Strong project management skills
•    Effective negotiation and problem-solving skills
•    Team Development
•    Strong attention to detail and deadlines
•    Excellent written and verbal communication skills including the ability to effectively communicate with a broad spectrum of people with varying backgrounds, education, and experience
•    Professional Certification (e.g., ASQ - CQA, CQE and/or CRE; RAB, internal/external courses, seminars) preferred
•    Strong reasoning ability to support and prioritize projects, adapt to shifting priorities, work with minimal supervision, and ability to resolve problems/conflicts
•    Ability to operate with appreciable latitude for actions or decisions on day-to-day activities. May require guidance on novel or controversial problems.
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The pay range for this position at commencement of employment is expected to be between $80,600- $100,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.