Abbott Laboratories
Sr. Quality Engineer
Abbott Laboratories, Temecula, California, United States, 92591
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 114,000 colleagues serve people in more than 160 countries.About AbbottFor years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.We are currently looking for a
Senior Quality Engineer.THIS POSITION IS ON-SITE DAILY.CAN BE BASED IN Temecula, CA, Santa Clara, CA or Westford, MA.WHAT YOU'LL DO:Perform Abbott Vascular data management quality engineering activities by developing and maintaining data integrity and cybersecurity policy, standards, applications, systems, etc. Work closely with R&D, Equipment Engineering, Quality Engineering and BTS on risk identification and mitigation activities. Facilitate cross functional team collaboration to achieve data management goals.MAIN RESPONSIBILITIESSupport AV data management project plan and perform assessment and mitigation with cross functional team. Develop and manage data management training program including training material and training audience. Track and report data management metrics.Provide support to internal and external audits. Manage data management audit findings and CAPAs.Continuously improve data management process to align with current and emerging regulatory and customer requirements and best industry practices. Collaborate with AV key stakeholders, Abbott corporate functional groups and other Abbott business units.Responsible for compliance with applicable Corporate and Divisional Policies and procedures.Independently, or lead a project team to, identify, plan and conduct medium-size assigned projects requiring a combination of conventional and custom risk-managed execution plans and investigations. Manage multiple often concurrent projects.Lead complex technical projects with multiple inter-coordinating elements where problem resolution may involve the application of new methods and/or approaches and may require consideration of impact with other system components and/or users.Lead and/or participate on cross-functional teams to support organizational goals.Responsible for completing documentation in a timely manner and in accordance with business standards.Serve as a subject matter expert (SME) on a subset or select subsets of a project's technical matters. May interface with external firms or agencies.Responsible for implementing the effectiveness and maintaining compliance of the Quality System. (e.g. compliance with internal procedures and FDA, BSI regulations etc).Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.Assists with evaluating project costs.Identifies, develops and implements processes to improve department performance.Directs Quality personnel to support quality system initiatives based on coordination with management, project leaders, & design engineers.Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.QUALIFICATIONSExperience/BackgroundMinimum EducationBachelor's degree (Engineering/Life Sciences) plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.ExperienceMinimum 6+ years. Requires 6-7 years of quality experience to develop the competence to meet the skills and responsibilities of the position.Strong technical knowledge and application of concepts, practices and procedures.Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.Ability to form and develop interpersonal, professional relationships.Display socially and professionally appropriate behavior.Ability to work independently and in groups.Ability to work cross-functionally.Demonstrated initiative and problem-solving skills.Critical-thinking skills.Ability and aptitude to use various types of databases and other computer software.Ability to prioritize.Strong organizational and project management skills.Demonstrated competency with financial systems and in fiscal controls.Ability to quickly gain knowledge, understanding or skills and is willing to learn.WHAT 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 priorityTraining 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:
www.abbottbenefits.comFollow 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
www.abbott.com , on Facebook at
www.facebook.com/Abbott
and on Twitter @AbbottNews and @AbbottGlobal.The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.
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Senior Quality Engineer.THIS POSITION IS ON-SITE DAILY.CAN BE BASED IN Temecula, CA, Santa Clara, CA or Westford, MA.WHAT YOU'LL DO:Perform Abbott Vascular data management quality engineering activities by developing and maintaining data integrity and cybersecurity policy, standards, applications, systems, etc. Work closely with R&D, Equipment Engineering, Quality Engineering and BTS on risk identification and mitigation activities. Facilitate cross functional team collaboration to achieve data management goals.MAIN RESPONSIBILITIESSupport AV data management project plan and perform assessment and mitigation with cross functional team. Develop and manage data management training program including training material and training audience. Track and report data management metrics.Provide support to internal and external audits. Manage data management audit findings and CAPAs.Continuously improve data management process to align with current and emerging regulatory and customer requirements and best industry practices. Collaborate with AV key stakeholders, Abbott corporate functional groups and other Abbott business units.Responsible for compliance with applicable Corporate and Divisional Policies and procedures.Independently, or lead a project team to, identify, plan and conduct medium-size assigned projects requiring a combination of conventional and custom risk-managed execution plans and investigations. Manage multiple often concurrent projects.Lead complex technical projects with multiple inter-coordinating elements where problem resolution may involve the application of new methods and/or approaches and may require consideration of impact with other system components and/or users.Lead and/or participate on cross-functional teams to support organizational goals.Responsible for completing documentation in a timely manner and in accordance with business standards.Serve as a subject matter expert (SME) on a subset or select subsets of a project's technical matters. May interface with external firms or agencies.Responsible for implementing the effectiveness and maintaining compliance of the Quality System. (e.g. compliance with internal procedures and FDA, BSI regulations etc).Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.Assists with evaluating project costs.Identifies, develops and implements processes to improve department performance.Directs Quality personnel to support quality system initiatives based on coordination with management, project leaders, & design engineers.Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.QUALIFICATIONSExperience/BackgroundMinimum EducationBachelor's degree (Engineering/Life Sciences) plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.ExperienceMinimum 6+ years. Requires 6-7 years of quality experience to develop the competence to meet the skills and responsibilities of the position.Strong technical knowledge and application of concepts, practices and procedures.Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.Ability to form and develop interpersonal, professional relationships.Display socially and professionally appropriate behavior.Ability to work independently and in groups.Ability to work cross-functionally.Demonstrated initiative and problem-solving skills.Critical-thinking skills.Ability and aptitude to use various types of databases and other computer software.Ability to prioritize.Strong organizational and project management skills.Demonstrated competency with financial systems and in fiscal controls.Ability to quickly gain knowledge, understanding or skills and is willing to learn.WHAT 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 priorityTraining 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:
www.abbottbenefits.comFollow 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
www.abbott.com , on Facebook at
www.facebook.com/Abbott
and on Twitter @AbbottNews and @AbbottGlobal.The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.
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