Senior Supplier Development Quality Engineer

Abbott • Los Angeles, CA

6d • Onsite

About The Position

This role is for a Sr. Supplier Development Quality Engineer for the CRM division, located in Sylmar, CA. As a global leader in Cardiac Rhythm Management, the division focuses on innovative technologies to improve the treatment of heart arrhythmias. The engineer will assure new or modified products conform to quality standards and establish compliance with the quality system. They will maintain a strong collaborative partnership with cross-functional team members to protect patient/user safety and meet business needs.

Requirements

• Bachelors Degree Engineering or Technical Field or an equivalent combination of education and work experience
• 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
• 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

Nice To Haves

• Master’s degree
• Prior medical device experience preferred
• ASQ CQE certification
• Design for Six Sigma and Critical to Quality training and experience
• Experience working in a broader enterprise/cross-division business model

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

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
• Excellent retirement savings plan with high employer contribution
• Tuition reimbursement
• Freedom 2 Save student debt program
• FreeU education benefit

What This Job Offers

• Job Type: Full-time
• Career Level: Senior