Senior Design Assurance Quality Engineer - Abbott (California)
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.
Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.
WHAT YOU’LL DO
Provide design assurance support for on-market medical devices. This role will be stewards of device’s design history files and will facilitate the application of design controls while supporting product development, manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
We are seeking a high caliber Senior Design Assurance Quality Engineer for the Design Assurance Engineering team. Each employee can make a difference and has the power, either individually or as a team, to continuously improve patient care and influence the success of the company. We are team-oriented, fast-paced, and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
• A Senior Design Assurance Quality Engineer provides ownership of the Design Control deliverables required to support on-market medical devices.
• Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
• Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
• Lead Risk Management activities from product Concept through Commercialization
• Support design test and inspection method development, and lead method validation activities
• Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
• Support and ensure internal & external audit responses and on-time product re-certifications
• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
• Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
• Support execution of biocompatibility and sterilization qualifications
• Develop, coach and lead other team members
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
• Performs other related duties and responsibilities, on occasion, as assigned
EDUCATION AND EXPERIENCE YOU’LL BRING
• Bachelor level degree in Engineering or Technical Field; advanced degree preferred
• 5+ years Quality engineering experience with product development and demonstrated use of Quality tools/methodologies
• Detailed knowledge of FDA, GMP, and ISO 13485
• Solid communication and interpersonal skills
• 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
• Prior medical device experience preferred
• ASQ CQE certification preferred
• Design for Six Sigma and Critical to Quality training and experience 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
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes and meets deadlines in timely, proactive manner
• Strong organizational, follow-up skills and attention to detail
• Ability to travel approximately 10%
• Ability to maintain regular and predictable attendance
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 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 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: ** www.abbottbenefits.com (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 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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
* This article was originally published here