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Senior Quality Engineer

Company: Evalve, Inc.
Location: westfield
Posted on: May 3, 2021

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries JOB DESCRIPTION:Job DescriptionWe are seeking an experienced, high caliber Senior Quality Engineer to be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplishgoals.Impact this role will have on Abbott:Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirementsLead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirementsLead, coach, and mentor non-exempt and entry level exempt personnelAssist in the development and execution of streamlined business systems which effectively identify and resolve quality issuesApply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issuesDesign and conduct experiments for process optimization and/or improvementAppropriately document experiment plans and results, including protocol writing and reportsLead process control and monitoring of CTQ parameters and specificationsLead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)Lead the investigation, resolution and prevention of product and process nonconformancesParticipate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)Lead in the completion and maintenance of risk analysisWork with design engineering in the completion of product verification and validationWork with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activitiesSupport all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignmentsMaintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendorsPerforms other related duties and responsibilities, on occasion, as assignedYour experience(s), education and knowledge will further expand Abbott's marketplace success:BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferredYour preferred qualifications and education:5+ years' experienceEngineering experience and demonstrated use of Quality tools/methodologiesDetailed knowledge of FDA, GMP, ISO 13485, and ISO 14971Solid communication and interpersonal skillsAdvanced computer skills, including statistical/data analysis and report writing skillsAbility to work in a highly matrixed and geographically diverse business environmentAbility to work within a team and as an individual contributor in a fast-paced, changing environmentAbility to leverage and/or engage others to accomplish projectsStrong verbal and written communications with ability to effectively communicate at multiple levels in the organizationMultitasks, prioritizes and meets deadlines in timely mannerStrong organizational and follow-up skills, as well as attention to detailAbility to travel approximately 10%Ability to maintain regular and predictable attendanceProject management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective mannerPrior medical device experience preferredExperience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)ASQ CQE or other certifications preferred JOB FAMILY:Engineering DIVISION:AVD Vascular LOCATION:United States > Westfield: 1820 Bastian Court ADDITIONAL LOCATIONS:WORK SHIFT:Standard TRAVEL:Yes, 5 % of the Time MEDICAL SURVEILLANCE:Not Applicable SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Keywords: Evalve, Inc., Westfield , Senior Quality Engineer, Other , westfield, Massachusetts

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