Senior Development Quality Engineer

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

Benefits offered by this job

Free medical coverage (HIP PPO)

High employer retirement contribution

Tuition reimbursement

FreeU education benefit

Great place to work

Job summary

Abbott is seeking a Senior Development Quality Engineer in the United States (Sylmar area). The role protects patient safety by ensuring products meet quality standards and collaborates across functions to align with business needs.

The ideal candidate has 5+ years in medical device quality engineering and understands FDA and ISO 13485 frameworks. The position requires leadership in Design Control, risk management, and verification/validation activities, with opportunities to mentor others and

Qualifications

• Minimum 5 years in quality engineering within medical devices.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Strong communication and leadership for cross-functional teams.
• ASQ CQE or DfSS training is a plus.

Responsibilities

• Lead on-time completion of Design Control Deliverables.
• Develop quality plans for internal development and OEM projects.
• Plan and execute Design Verification and Validation activities.
• Lead risk management from concept to commercialization.
• Ensure DHF content integrity and regulatory compliance.
• Support manufacturing process development and product changes.
• Coordinate internal/external audit responses and CAPA.
• Develop and mentor team members.

Skills

Quality engineering

FDA knowledge

GMP knowledge

ISO 13485 knowledge

Project management

Leadership

Education

Bachelor's degree in Engineering or Technical Field

Master's degree - Preferred

Tools

Statistical analysis

Job description

JOB DESCRIPTION:

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

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-certificationsSupport 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.

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

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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf