Position Description:
Sr. Quality Engineer for Medtronic, Inc located in Santa Ana, CA. Develop, modify, apply and maintain quality standards and protocols for processing materials into subassemblies or finished device, develop and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production/testing equipment; conduct quality assurance tests; and perform statistical analysis to assess the reliability and capability of processes and products. Leverage Quality Engineering for medical device components meeting specifications. Navigate government and industry regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, European Union (EU) Medical Device Regulation (MDR), State of the Art (SOTA) and Good Manufacturing Practices (GMP). Coordinate Risk Assessments including Preliminary Hazard Analysis (PHA), Process Failure Mode Effect Analysis (PFMEA) and ISO 14971 Risk Mgmt. for Medical Devices. Coordinate Non-Conformances, Complaints and Corrective and Preventive Actions (CAPA). Leverage Process Improvement Tools including Define, Measure, Analyze, Improve, and Control (DMAIC), Root Cause Analysis, 5Whys, Fishbone and cause mapping. Leverage Design of Experiments (DOE) methods to establish process development. Develop of V&V (verification and validation), IQ, OQ, and PQ. Leverage knowledge of and work with animal tissue processing including porcine and bovine. Relocation Assistance is not available for this position. #LI-DNI.
Basic Qualifications:
Bachelors’ Degree or foreign equivalent in Mechanical, Industrial, Biomedical Engineering, Nanoengineering, or related engineering field and four (4) years of experience as a quality or manufacturing engineer for medical devices. Or alternatively, Masters’ Degree or foreign equivalent in Mechanical, Industrial, or Biomedical Engineering, Nanoengineering or related engineering field and two (2) years of experience as a quality or manufacturing engineer for medical devices. Must possess at least two (2) years’ experience with each of the following: 21 CFR Part 820, ISO 13485, EU MDR, SOTA, and GMP; PHA, PFMEA, and ISO 14971; Non-Conformances and CAPA; DMAIC, Root Cause Analysis, 5Whys, Fishbone, and cause mapping; DOE and process development; Development of V&V & IQ/ OQ/ PQ; Animal tissue processing including porcine and bovine.
Salary: $108,500 to $141,600 per year
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We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
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