Job details
Job type full-time
Full job description
Abbott is a global healthcare leader that helps people live more fully at all stages of lifeOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicinesOur 109,000 colleagues serve people in more than 160 countries.
Senior design quality engineer ii
Pomona or, san diego, or remote
Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis, and treatment of a range of health conditions.
Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your healthWe’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of lifeEvery day, more than 10 million tests are run on abbott’s diagnostics instruments, providing lab results for millions of people.
Our location in pomona or, san diego, or remote currently has an opportunity for a senior design quality engineer iiThis role will be responsible for quality engineering activities that address product/process changes, product/process quality issues, and compliance issuesThis person will partner with operations for process improvement and continuous improvement initiatives and perform process audits of the operations areasThis person may be involved in the development of new products and as such would support design control activities.
What you’ll do
Lead quality assurance support in the design and development/on market support of in-vitro diagnostics (ivd) medical device products, facilitating the application of design/change controls, risk management, quality plan and implementation of design and development plan.
Create and maintain risk management files such as umfmea/dfmea/pfmea that identify hazard analysis critical control points (haccp) and are compliant with the requirements of iso 14971:2019.
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
Work closely with r&d, manufacturing, quality control, and applications support management to prevent non-conformities and provide solutions to complex issues.
Lead and support multiple projects, balancing priorities and resources to meet project and management expectations.
Review and approve proposed changes for on market products by performing risk assessments, providing guidance and support and assessing the adequacy of verifications and validations and dmr documents.
Review and approve verification and process validation, equipment qualification documents.
May coordinate activities of other personnel.
Lead process improvement projects
Act as sme for key subsystems such as design control, risk management, design verification, design validation, process validation etc.
Act as a mentor to quality engineers/qa staff
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices
Understands and is aware of the quality consequences which may occur from the improper performance of their specific jobHas awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
Carries out duties in compliance with established business policies
Demonstrates commitment to the development, implementation and effectiveness of quality management system per iso, fda, and other regulatory agencies
Perform other duties and projects as assigned
Education and experience you’ll bring
Required
Bs/ba degree in field of science such as chemistry, microbiology, biology, biochemistry or engineering
Minimum of 9 years’ of experience in a quality role within the biotechnology industry with 8 years of progressively responsible positions
Minimum of 7 years hands-on risk management experience in maintaining risk management files such as umfmea/dfmea/pfmea, plans, reports, etc.
Minimum of 7 years of quality assurance engineering experience (design controls, change control, on market quality engineering support and/or new project introduction)
Minimum of 7 years of capa system, non-conformity system and/or manufacturing process improvement experience.
Experience reviewing and approving process validations, equipment qualifications, required.
Experience reviewing and approving device master record (dmr) documents required.
Preferred
Direct work experience in ivd or medical device/biotech or regulated manufacturing environment.
Experience acting as quality lead supporting new product development desired.
Experience with transferring a product from development to production desired.
Hands on design verification, design validation and design history file (dhf) desired.
Process, qms or supplier auditing experience desired.
Experience with reagent, elisa, heia manufacturing desired.
Lean six sigma (black or green belt), certified quality engineer, certified quality auditor desired.
Knowledge of ivdr in eu, fda qsrs, iso 13485:2016, iso 14971:2019 standards.
Goal oriented, learns quickly, works in a collaborative manner with other departments.
Strong writing and verbal communication skills.
Knowledge of computers and software programs including word, excel, access, visio, ms project, minitab, powerpoint and agile.
Experience with root cause analysis, failure mode analysis, verification, and validation
Statistical tools including basic statistical inference, graphical methods, regression.
Experience with process validations, design verification and design validation studies
Knowledge of quality system regulations
Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor
Must be detail-orientated, self-motivated and available for flexible scheduling
What we offer
At abbott, you can have a good job that can grow into a great careerWe offer:
A fast-paced work environment where your safety is our priority
Production areas that are clean, well-lit, and temperature-controlled
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives, and retirement plans
Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and a history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx
Follow your career aspirations to abbott for diverse opportunities with a company that provides the growth and strength to build your futureAbbott is an equal opportunity employer, committed to employee diversity.
Connect with us at www.abbott.com, on linkedin at www.linkedin.com/company/abbott-/, on facebook at http://www.facebook.com/abbott and on twitter @abbottnews.
