Main Responsibilities
Lead on-time completion of Design Control Deliverables
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
Lead 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/lead and ensure internal & external audit responses
Support/lead and ensure 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
Accountable for development, execution and analysis of biocompatibility and sterilization qualifications
Complete Document Change Request Reviews in a timely and objective manner
Develop and lead other team members.
Perform other duties and responsibilities as assigned by management.
Support/lead 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.
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.
Qualification
Bachelors Degree (± 16 years) - Engineering or Technical Field or an equivalent combination of education and work experience
Masters Degree (± 18 years) - Preferred
Experience / Background
Minimum 5 years
Previous Quality engineering experience 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 manner. Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel approximately 10%, including internationally.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.
- The base pay for this position is
- $90,000.00 – $180,000.00
- 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
