Quality Assurance and Supplier Development Engineer

1 day ago

Pleasanton, California, United States Abbott Laboratories Full time

At Abbott Laboratories, we are committed to helping people live more fully at all stages of life. As a global healthcare leader, our portfolio of life-changing technologies spans the spectrum of healthcare.

Main Purpose:

We are seeking a Quality Assurance and Supplier Development Engineer to join our team. This role is responsible for activities related to supplier selection and evaluation, material qualification, supplier performance, and receiving inspection.

Main Responsibilities:

  • Contribute to the development, maintenance, and improvement of division supplier development quality program policies, procedures, and forms.
  • Provide coaching and mentoring for technical team personnel.
  • Guidance and training to Purchasing, R&D, Manufacturing, and Quality engineers in applying program requirements.
  • Reviews and approves all supplied product drawings and component quality plans.
  • Manages development of supplied product inspection procedures and first article requirements.
  • Provides engineering guidance to division Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies, and inspection procedures.
  • Assesses supplier capabilities through direct visits, technical discussions, directed testing, and quality system audits.
  • Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests, and technical discussions.
  • Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews.
  • Contributes and participates in supplier performance reviews.
  • Evaluates and develops Supplied Data Agreement partnerships with suppliers.
  • Applies sound engineering analysis and judgment to reduce the need for inspection in accordance with program policies.
  • Works with Manufacturing engineering to assess and address purchased product issues.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Design and conduct experiments for process optimization and/or improvement.
  • Participate in or lead teams in supporting Supplier Development Quality program requirements.

This role requires a strong understanding of FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. You will maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Requirements:

  • Bachelor's degree in engineering or Technical Field.
  • Advanced degree preferred.
  • Minimum 5 years Related experience. Prior medical device experience preferred.
  • Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies.
  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
  • Solid communication and interpersonal skills.
  • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
  • Advanced computer skills, including statistical/data analysis and report writing skills.
  • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). ASQ CQE or other certifications preferred.
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

Salary: $83,600 - $167,200 depending on location.

  • Quality Assurance Engineer for Supplier Partnerships

    2 weeks ago

    Pleasanton, California, United States Techlink Systems Full time

    At TechLink Systems, we are seeking a skilled Quality Assurance Engineer to join our team and play a vital role in establishing and maintaining strong supplier partnerships. This dynamic position offers an excellent opportunity to leverage your expertise in quality engineering principles and practices to drive excellence in supplier performance.About the...

  • Quality Assurance Manager

    2 weeks ago

    Pleasanton, California, United States Prokatchers Full time

    Job OverviewWe are seeking a highly skilled Quality Assurance Manager to join our team at Prokatchers in Pleasanton, CA. This role is responsible for developing and maintaining the division supplier development quality program policies, procedures, and forms.The ideal candidate will have a strong background in Software as a Medical Device (SaMD) and Class...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Pleasanton, California, United States GTT, LLC Full time

    Job SummaryThis is a unique opportunity to play a critical role in ensuring the quality and reliability of products by managing supplier performance and implementing robust quality systems.About the RoleAs a Senior Supplier Quality Engineer, you will work closely with cross-functional teams to identify, assess, and mitigate supply chain risks. Your key...

  • Senior Mobile Quality Assurance Engineer

    2 weeks ago

    Pleasanton, California, United States Bayone Full time

    Job Title: Senior Mobile Quality Assurance EngineerAbout BayoneBayone is a technology-driven company that provides innovative solutions for the mobile industry.Job SummaryWe are seeking an experienced Senior Mobile Quality Assurance (QA) Automation Engineer to lead our QA team and ensure the delivery of high-quality mobile applications. The ideal candidate...

  • Highly Skilled Software Quality Assurance Engineer

    2 weeks ago

    Pleasanton, California, United States Unchained Labs Full time

    Unleash Your Expertise as a Top-Quality Software TesterAt Unchained Labs, we're on a mission to revolutionize life science research tools. We're passionate about developing cutting-edge products that make a real difference in the world. As a highly skilled software quality assurance engineer, you'll be at the forefront of this innovation, leading testing...

  • External Supplier Partnership Manager

    1 week ago

    Pleasanton, California, United States Nesco Resource Full time

    At Nesco Resource, we are seeking an experienced External Supplier Partnership Manager to join our team. This is a challenging role that requires a unique blend of business acumen, technical expertise, and interpersonal skills.About the RoleThis position will be responsible for managing relationships with key suppliers and ensuring that their partnerships...

  • Digital Quality Assurance Leader for Cloud and Mobile Solutions

    16 hours ago

    Pleasanton, California, United States Abbott Laboratories Full time

    Job DescriptionAward-winning Abbott Laboratories is seeking a seasoned Digital Quality Assurance Leader to spearhead our cloud and mobile solutions portfolio. As a Senior Manager, Software Development Engineer in Test (SDET), you will be responsible for leading a team of SDETs in ensuring the quality and reliability of our medical device software...

  • Cloud Quality Assurance Engineer

    2 weeks ago

    Pleasanton, California, United States Oracle Full time

    About OracleAs a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's problems. True innovation starts with diverse perspectives and various abilities and backgrounds.We're committed to expanding our inclusive workforce that promotes diverse insights and perspectives. We've partnered with industry-leaders in almost every...

  • Food Quality Assurance Specialist

    1 week ago

    Pleasanton, California, United States Chili's Grill & Bar Full time

    About UsChili's Grill & Bar is a leading casual dining restaurant chain that was founded in Dallas, Texas in 1975.We are committed to delivering the best experience to every Guest, every day, and our legacy is deeply rooted in service, hospitality, and giving back.Job OverviewAs a Food Quality Assurance Specialist at Chili's, you will play a vital...

  • Senior Mechanical Engineer, Plastics NPI Expert

    2 weeks ago

    Pleasanton, California, United States 10X Genomics Full time

    About 10x GenomicsAt 10x Genomics, we're accelerating our understanding of biology to change the world. We empower scientists to advance their research and address questions they never thought possible.Our teams are passionate about following their ideas and pursuing new discoveries in an inclusive environment. Behind every breakthrough is a talented team...

  • Lead Power Systems Design Engineer

    2 weeks ago

    Pleasanton, California, United States K&A Engineering Consulting PC Full time

    K&A Engineering Consulting PC is a people-first organization that values knowledge, learning, and collaboration. Our team of experts is dedicated to providing comprehensive consulting, engineering, and design services to power utility and industrial clients.We are seeking a highly skilled Senior Distribution Design Engineer to join our team in Pleasanton,...

  • Highly Skilled Mechanical Design Engineer

    2 weeks ago

    Pleasanton, California, United States 10X Genomics Full time

    About 10x Genomics:At 10x Genomics, we accelerate our understanding of biology with a commitment to advancing research in life sciences. Our tools enable scientists to explore questions they did not even know they could ask, making breakthroughs possible across biology including cancer, immunology, and neuroscience.Design Engineer Role OverviewWe are seeking...

  • Lead Java Developer with Cloud Expertise

    2 weeks ago

    Pleasanton, California, United States Nisum Full time

    Nisum, a leading global digital commerce firm headquartered in California, specializes in digital strategy and transformation. With over 1,800 professionals across the United States, Chile, Colombia, India, Pakistan, and Canada, Nisum offers custom software development services to Fortune 500 brands.Job OverviewThis role is responsible for planning,...

  • Lead Mechanical Design Engineer for Next-Generation Medical Devices

    2 weeks ago

    Pleasanton, California, United States AtriCure, Inc. Full time

    AtriCure, Inc. is seeking a skilled Senior Mechanical Engineer to lead or work on project teams planning and supporting projects, including the design, build, and test of next-generation medical devices or significant improvements to existing products used by cardiac surgeons and electrophysiologists. As a key member of our team, you will be responsible for...

  • Java Developer

    2 weeks ago

    Pleasanton, California, United States Nisum Full time

    Nisum is a leading global digital commerce firm headquartered in California. With services spanning digital strategy, transformation, insights and analytics, blockchain, business agility, and custom software development, the company has grown to over 1,800 professionals across the United States, Chile, Colombia, India, Pakistan, and Canada.Role OverviewWe...

  • Technical Lead

    1 day ago

    Pleasanton, California, United States Abbott Laboratories Full time

    About the OpportunityAbbott Laboratories, a global healthcare leader, is seeking an experienced Senior Staff RF Engineer to join our Heart Failure division in Pleasanton, CA. As a key member of our team, you will contribute to the development and release of next-generation CardioMEMS products that remotely monitor pulmonary artery pressure, aiding physicians...

  • Chief Systems Engineering Strategist

    2 weeks ago

    Pleasanton, California, United States Abbott Laboratories Full time

    Job DescriptionWe are seeking a Chief Systems Engineering Strategist to lead our Systems Engineering team in driving technical direction and ensuring business objectives are met.The successful candidate will have a strong track record of technical leadership, with experience in applying systems engineering tools and practices in product development.Main...

  • Senior Product Development Engineer

    2 weeks ago

    Pleasanton, California, United States 180Engineering Full time

    Job OverviewAt 180Engineering, we're seeking a highly skilled Senior Product Development Engineer to join our team. This is an exceptional opportunity to leverage your expertise in mechanical design and product development to create innovative solutions for MRI receiver coils.

  • Senior Software Engineer

    2 weeks ago

    Pleasanton, California, United States Saxon Global Full time

    Job Summary:Sr. AngularJS Engineer position available for long-term contract, requiring local presence in the Bay Area.

  • Biological Instrumentation Control Software Developer

    2 weeks ago

    Pleasanton, California, United States 10x Genomics Full time

    Role OverviewWe are seeking a skilled Biological Instrumentation Control Software Developer to join our esteemed Instrument Software team at 10x Genomics. As a key member of our team, you will design and develop advanced embedded control software and firmware for cutting-edge biological instrumentation platforms.About the RoleJob Summary: Design and develop...