This is a fully onsite role.
A Development Quality/Design Assurance Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. 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.
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
WHAT YOU’LL DO
Execute and support on-time completion of Design Control Deliverables.
Accountable for Electrical Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities.
Lead or support Risk Management activities from product Concept through Commercialization.
Support electrical design test and inspection method development, and lead method validation activities.
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.
Support manufacturing process development & qualification for new product commercialization and product changes.
Support internal & external audits and audit responses.
Support product re-certifications.
Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications.
Complete Document Change Request Reviews in a timely and objective manner.
Additional duties may be identified by functional management based on the current project/business objectives.
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.
Required Qualifications
Bachelor’s Degree in Engineering or Technical Field or an equivalent combination of education and work experience.
2 years of quality engineering experience and demonstrated use of Quality tools/methodologies
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 manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel approximately 10%, including international.
Preferred Qualifications
Masters Degree
- The base pay for this position is
- $81,500.00 – $141,300.00
- In specific locations, the pay range may vary from the range posted.
JOB FAMILY
Operations Quality
DIVISION
CRM Cardiac Rhythm Management
LOCATION
United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS
WORK SHIFT
Standard
TRAVEL
Yes, 10 % of the Time
MEDICAL SURVEILLANCE
Not Applicable
SIGNIFICANT WORK ACTIVITIES
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
