Senior Development Quality Engineer

Abbott • Los Angeles, CA

2d • $90,000 - $180,000

About The Position

The Senior Development Quality Engineer assures that new or modified products conform to quality standards and establishes compliance with the quality system. The role builds and maintains collaborative partnerships with cross-functional team members to protect patient and user safety while meeting business needs.

The engineer leads design control deliverables, quality planning, design verification and validation, risk management, and the development and validation of test and inspection methods. The position helps ensure design history file integrity and regulatory compliance, supports manufacturing process development and qualification, and contributes to audits, product recertifications, customer and product requirements, component specifications, supplier qualifications, biocompatibility, and sterilization qualifications. The role also reviews document change requests, develops and leads team members, supports company and quality-system initiatives, and complies with applicable FDA regulations, other regulatory requirements, and company procedures.

The role is based in Sylmar, California, and requires approximately 10% travel, including international travel. The posted base pay range is $90,000–$180,000, with possible variation by location.

Requirements

• Bachelor’s degree in engineering or a technical field, or an equivalent combination of education and work experience.
• At least 5 years of experience.
• Previous quality engineering experience and demonstrated use of quality tools and methodologies.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Solid communication and interpersonal skills.
• Project management and leadership skills, including demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical and data analysis and report writing.
• 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 or engage others to accomplish projects.
• Strong verbal and written communication skills, including the ability to communicate effectively at multiple levels of the organization.
• Ability to multitask, prioritize, and meet deadlines in a timely manner.
• Strong organizational and follow-up skills and attention to detail.
• Ability to travel approximately 10%, including internationally.

Nice To Haves

• Master’s degree preferred.
• 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 or cross-division business unit model preferred.

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.
• Plan and execute Design Verification and Validation, including cross-functional root-cause analysis investigation and resolution activities.
• Lead Risk Management activities from product concept through commercialization.
• Lead design test and inspection method development and method validation activities.
• Ensure Design History File (DHF) content completion, integrity, and regulatory and standards compliance; communicate and resolve gaps collaboratively.
• Support manufacturing process development and qualification for new product commercialization and product changes.
• Support or lead internal and external audit responses.
• Support or lead on-time product recertifications.
• Support and ensure 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.
• Develop, execute, and analyze 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 assigned by management.
• Support and lead company initiatives identified by management in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with employees at all levels, customers, contractors, and vendors.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to earning a bachelor’s degree.

What This Job Offers

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