Development Quality Engineer II

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 114,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

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.

The Opportunity 

A Development Quality 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.

What You Will Work On

• Execute and support on-time completion of Design Control Deliverables.

• Support 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 or support Risk Management activities from product Concept through Commercialization.

• Support 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 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.

• Support execution of biocompatibility and sterilization 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

• Bachelors Degree (± 16 years) in an Engineering or Technical Field (or) an equivalent combination of education and work experience

• Masters Degree (± 18 years) 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 manner.

• Strong organizational and follow-up skills, as well as attention to detail.

• Ability to travel approximately 10%, including internationally.

The base pay for this position is

$79,500.00 – $138,700.00

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