Quality Systems Engineer II

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 109,000 colleagues serve people in more than 160 countries.Our Neuromodulation business is an area of expertise for Abbott. This business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. Our Solutions include Proclaim (TM) XR SCS System, the 1 Spinal cord stimulator on the market, Proclaim (TM) DRG Neurostimulator, the only FDA approved DRG therapy and a market leader in radiofrequency ablation therapy, Abbott RFA. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Our deep brain stimulation technology for progressive diseases help people manage their Parkinson''s disease and essential tremor symptoms, steering away from side effects.Our location in Plano, TX, currently has an opportunity for a Quality Systems Engineer II. The Quality Systems Engineer II, Quality Systems is an individual contributor primarily responsible for managing and maintaining the product and Quality Management System (QMS) regulations and standards management system, and contributing to the maintenance of the QMS. Work requires the understanding and application of standards, theoretical principals, understanding of the product development lifecycle, using creative and analytical techniques, and effective communication.WHAT YOU''LL DOManages, maintains, and improves processes related to the compliance of regulatory standards management system.Exercises judgment in planning, organizing, performing, and/or coordinating projects by working with internal customers (e.g., Regulatory Affairs, Quality, Engineering, and Upper Management) This position is responsible for developing and maintaining quality system elements and providing quality system support within Abbott organizations.Identifies and routinely uses the most effective and efficient methods (i.e., best practices) to execute processes; continually evaluates their effectiveness and appropriateness. Follows the tracking of product and QMS standards and regulations implementation throughout the entire lifecycle.Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirementsLead the investigation, resolution and prevention of product and process non-conformancesIdentifies changes to regulations and standards, which may affect Quality System or product, and coordinates activities needed to ensure complianceAs appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member)Investigates, and resolves system non-conformances (defined during internal and/or external audits).Develops QS related reports (e.g., quality plans & reports, process documentation, gap assessments) to support business activitiesAs appropriate, identify improvement opportunities in quality system compliance (device and process) and utilize quality tools to implement process improvements to enhance product quality and reduce process variance.Facilitates core Quality System activities (e.g. Management Review preparation, External Standards, Org Responsibility, Quality Manual) to meet process requirementsApply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issuesCompletes tasks related to internal/external audit preparation and execution as neededTracks Quality status of quality records and facilitate their timely closureSupport all Abbott initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), Learning Management Systems (LMS) and other regulatory requirementsComply with U.S. and international regulations for medical devices, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendorsPerforms other related duties and responsibilities, on occasion, as assignedEDUCATION AND EXPERIENCE YOU''LL BRINGRequiredBachelor''s degree in an engineering or scientific/technical discipline2+ years of related experience, preferably in an FDA-regulated industry (e.g., medical device, pharmaceutical, biotech)Demonstrated and impactful project management experience.Experience leading a project team and resolving quality system-related issues in a timely and effective manner.Strong communication skills to maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Ability to multitask, prioritize and meet deadlines in a timely mannerAdvanced computer skills, including statistical/data analysis and report writing skillsPreferredCertification (e.g., ASQ) or training in relevant Quality disciplines such as Quality Engineering, Auditing, or Six SigmaTraining in QMS requirements (e.g., FDA QSR 21 CFR 820; ISO 13485)Experience implementing process improvement methodologies (e.g., Six Sigma, Lean).Engineering, change control, and project management experienceCAPA root cause analysis and resolution, and audit NC remediation experienceKnowledge of Quality tools/methodologiesStrong computer skills in Microsoft Word, Excel, PowerPoint, and Visio or equivalent office suite softwareAbility to query databases and refine data into summarized resultsWHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:A fast-paced work environment where your safety is our priority (Include for Manufacturing roles only)Production areas that are clean, well-lit and temperature-controlled (Include for Manufacturing roles only)Training and career development, with onboarding programs for new employees and tuition assistanceFinancial security through competitive compensation, incentives and retirement plansHealth care and well-being programs including medical, dental, vision, wellness and occupational health programsPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

Created: 2021-11-29