Senior Development Quality Engineer

Abbott Laboratories; Los Angeles (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Tuition reimbursement

Job summary

Abbott in Los Angeles, CA, seeks a Senior Development Quality Engineer to assure new or modified products meet quality standards and FDA/regulatory requirements.

You will lead design verification, risk management, DHF, audits, and cross-functional collaboration to protect patient safety and support commercialization.

Qualifications include 5+ years in quality engineering, FDA/GMP/ISO 13485 knowledge, and strong communication; travel up to 10%.

Qualifications

• Minimum 5 years of quality engineering experience with FDA, GMP, and ISO 13485 knowledge.
• Strong communication and interpersonal skills; ability to lead multi-department projects.
• Experience with cross-functional teams and regulatory inspections is required.
• ASQ CQE certification preferred.
• Design for Six Sigma/CTQ training preferred.

Responsibilities

• Create and ensure on-time execution of Quality Plans for development, OEM, CPDP and design changes.
• Lead Design Verification and Validation planning and execution with cross-functional analysis.
• Lead Risk Management from concept to commercialization.
• Develop and validate test methods and inspection plans.
• Ensure DHF content, regulatory compliance, and communicate gaps.
• Support manufacturing process development and qualification for new products.
• Coordinate internal & external audit responses and re-certifications.
• Establish objective product and component requirements and supplier qualifications.
• Develop biocompatibility and sterilization qualifications; manage documentation reviews.

Skills

Quality engineering

Project management

Leadership

Statistical analysis

Communication

Education

Bachelor's degree in Engineering/Technical Field

Master's degree (preferred)

Job description

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 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

Main Purpose of the Role

The Senior 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.

Main Responsibilities

• 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.

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.