Quality Engineer at American Regent

Nature and ScopeThe Quality Engineer must demonstrate a sound knowledge application and proper implementation of technical quality and scientific principals necessary to meet industry and customer requirements. The Quality Engineer has the primary responsibility of providing Quality Assurance input to all aspects of Validated systems.Essential Duties and ResponsibilitiesNothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.Preparation/review of Quality Assurance Validation and Quality Control protocols and reports covering complex systems such as ProcessValidation computer-controlled systems validation complex utilities complex manufacturing equipment such as filling systems formulation systems and knowledge of laboratory validation.Works closely with other members of plant quality manufacturing calibration services and R&D organizations to accomplish overall objectives; and understand cGMP and other FDA Guidance Documents as well as the current processes and practices that are current and ongoing at the American Regent manufacturing/packaging siteIdentify key quality issues and assist their resolution.Employ knowledge of process improvement techniques and tools such as the DMAIC model FMEAprocess Flow Diagram Affinity Diagram Pareto Control Charts (SCP) Run Charts SOP etc.Perform any other tasks/duties as assigned by management.Education Requirements and QualificationsTo perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.Minimum of 3 years in an FDA regulated environment required preferably in an Engineering or Validation capacity.Bachelors degree in Engineering or Science required. Masters degree preferred.Strong working knowledge of cGMP and Federal (FDA) requirements and guidelines.Strong technical writing skills and knowledge of Good Documentation Practices.Strong knowledge of computer software including Word Excel and PowerPoint.Ability to interface with senior level employees from multiple departments.Physical Environment and RequirementsWhile performing duties of the job incumbent is occasionally required to stand; walk; sit; use hands to finger handle or feel objects tools or controls; reach with hands and arms; balance; talk and hear.Expected Salary Range:$79900 - $90000The salary range displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidates qualifications education knowledge skills and experience.American Regent also offers a competitive total rewards package which includes healthcare life insurance profit sharing paid time off matching 401k as well as a wide range of other benefits.American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status or protected veteran status.Applicants have rights under Federal Employment Laws. FMLA poster: Your Rights: Know Your Rights: Workplace discrimination is illegal ()Employee Polygraph Protection Act: Were aware of individuals impersonating our staff to target job seekers. Please note: All legitimate communication will come directly from a verified ARI recruiter either by phone or via an email address. Our recruiting process includes multiple in person and/or video interviews and assessments. If you are unsure about the legitimacy of a message contact John Rossini at before responding. We never request payment bank information or personal financial details during our offer process.Your security is important to us and we encourage you to stay vigilant when job searching.American Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process please email . Key Skills APQP,Quality Assurance,Six Sigma,ISO 9001,PPAP,Minitab,Root cause Analysis,ISO 13485,Quality Systems,Quality Management,As9100,Manufacturing Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 79900 - 90000