Lead Process Quality Engineer

At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy. The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida. Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide. www.terumoaortic.com Position Summary Responsible for leading the process quality engineering team and providing quality engineering support to the CEA, Pre & Post Sterilization areas.   Responsible for ensuring assigned area(s) compliance with internal procedures.  Supports the NCR process to ensure assigned areas are processing NCRs in a timely manner. Supports / leads review of non-conforming product to determine appropriate dispositions along with product risk assessment and perform product failure investigations.  Provided quality assurance guidance to the mfg. teams.  Reports on the performance of the assigned quality areas.  Develops / approves quality standards and controls. Develops / approves product and process qualifications/validation protocols/reports.   Advises company management on quality assurance requirements and needs.  Drives Supplier and Production Quality improvements, including efficiency and productivity improvements while maintaining compliance with internal requirements.   Key Accountabilities: ·         Leads and guides the assigned process quality engineering team.  ·         Participates in the nonconformance process to ensure timely generation and closure of NCRs.   ·         Identifies, reports and monitors nonconforming events for the areas of responsibility. ·         Oversees the Nonconformance process to ensure their timely generation and closure. ·         Performs product or process failure investigations and implements corrective and preventive actions to prevent reoccurrence ·         Interacts with cross-functional teams to resolve quality issues ·         Develops Quality Instructions and Quality Standards. ·         Responsible for development and improvement of assigned area(s) inspection methods, including their TMVs. ·         Suggests, implements, reviews and approves engineering changes to product or processes. ·         Prepare, review, execute, and generate assigned protocols / reports. ·         Provides QA support to the assigned areas and responds to Internal Audits, takes actions as appropriate based on CAPAs, Complaint investigations, Nonconforming events, etc. ·         Applies knowledge in Quality Systems to execute overall project assignments ·         Applies statistical tools to analyze data and identify root cause and problem resolution ·         Recommends decisions on administrative or operational matters and ensures assigned quality assurance team’s effective achievement of objectives. ·         Ensures quality system compliance for area(s) of responsibility. ·         Serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for corrective and preventive actions. ·         Provide guidance / Mentor assigned engineers. ·         Drive quality systems improvements Internal Networking/Key relationships This position requires cooperating with different company departments, such as Customer Service, Regulatory Affairs, Manufacturing, R&D Engineering and other TAS / TAG departments.   Minimum Skills & Capabilities: ·         Works with all levels within the company. ·         Ability to organize and conduct multiple, parallel tasks ·         Excellent Written and Verbal Communication ·         Understanding of quality system regulations (ISO13485, 21CFR820) ·         Ability to interact with all levels within organization ·         Analytical skills for compiling and analyzing data ·         Knowledge of DOE, SPC, Gage R&R, and sampling plans ·         Ability to motivate & lead teams and improve process efficiency ·         Six Sigma Certification a plus ·         ASQ Quality Engineer Certification a plus ·         Basic statistical and data analysis Minimum Knowledge & Experience required for the position: ·         Bachelor’s degree in a technical discipline (Engineering or Science) or equivalent, with a minimum of five years of experience in medical device quality assurance. ·         Minimum 5 years’ experience in Manufacturing Engineering or Quality Engineering with validation experience ·         Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) - ISO 13485 and ISO 14971). ·         Leadership ability and organizational skills. ·         Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work. ·         Must have experience handling nonconforming events ·         SAP knowledge is a plus   It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.