Quality Systems Analyst

Job Category:  Quality Assurance/Safety Reference Code:  US_EN_1_025158_7641839 Location:  Wallingford, CT 06492 Job Status:  Full Time, Employee Job Description:DESCRIPTION:Outcomes: The successful candidate will:o Act as liaison between Quality Assurance and other RI groups to insure evaluations, investigations, and CAPA’s are processed in a timely manner.o Review and determine the applicability/effectiveness of complaint evaluationso Ability to identify potential reportable quality trends and issues.o Compile data for daily, weekly and monthly reports relative to product and process quality.o Compile data for post market surveillance activities.o Complete records review, prepare records for record retention and retrieve records as needed.o Facilitate, assist and/or conduct quality system activities, prepare reports and follow up on auditso Respond to customers, institutions, and/or various agencies requests for informationo Perform non-technical evaluations, document and effectively communicate root cause findings.o Generate reports and maintain files, as required.o Occasionally support other QA functions as required.Behaviors: The successful candidate will demonstrate:o Judgment & Decision Making ?? Possess the ability to make sound decisions with regard to Quality/Regulatory related matters ensuring that QA/RA interests are maintained.o Team Oriented ?? Ability to work with others to accomplish assignments / tasks.o Teaming - Leveraging available resources and capabilitieso Aptitude - the ability to expand this role by identifying innovative solutions to support Service notifications and CAPA handling processes. The ability to effectively communicate with the International sites and Customer Service to insure RI & RICT quality interests are maintainedo Schedule Orientation - practical use of time to complete task; promptness and punctuality in meeting obligations. (internal/external) to execute and achieve defined goals. Exceptional Planning and organizational skillso A Commitment to Quality - Demonstrate a solid commitment to the principles and practices that result in quality product and services; insuring satisfied customers with continual improvement as a primary focusGrowth: The successful candidate will:o Be self-motivated and self-directed with the ability to work independently and seek guidance when needed.o Take accountability to execute personal development plans to grow within current roleo Continue to learn about Respironics' products and pursue ongoing education to broaden knowledge base and expand current role.QUALIFICATIONSEDUCATION:o Associates Degree plus 5 years relevant experience in an area relating to Quality with technical or medical device manufacturer experience.EXPERIENCE:o Required:o Customer/agency interface and correspondence skills.o Proficient in MS Word, Excel and Outlook or equivalent applications.o Experience working within the framework of a Quality Management System which is subject to QSR and ISO requirements.o Must be detail-oriented and highly organized.o Ability to understand and interpret detailed technical reports/evaluationso Ability to coordinate multiple tasks efficiently.o Proficient in reading, writing and speaking Englisho Good written and verbal communication skills with emphasis on documenting root cause determinations.o Preferred:o SAP experience a pluso Technical writing experienceMinimum Education Required: BachelorYears of Experience Required: At Least 3 YearsExpected Travel Time: None About Adecco North America Adecco is a Fortune Global 500 company and the world leader in workforce solutions. Our comprehensive service offering includes temporary and contract staffing, permanent recruitment, outplacement and career services, training and consulting.