Sr. Quality Engineer - NPD in Irvine, CA at Apex Life Sciences

Date Posted: 9/11/2018

Job Snapshot

Job Description

R&D Engineer


Implement design control and product development activity to bring new or refined products to market.

Develop test and inspection tools and methods.  Validate test methods.

Develop supplier qualification test and inspection tools. Lead communication and tracking with supplier for validation activities. 

Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. 

Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. 

Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk. 

Develop, update, and maintain technical content of risk management files 

Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes 

Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. 

Train, coach, and guide lower level employees on routine procedures


• Proven expertise in usage of MS Office Suite; CAD experience preferred; Minitab Process understanding

• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills 

• Working knowledge and understanding of statistical techniques 

• Previous experience working with lab/industrial equipment required 

• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering 

• Strong problem-solving, organizational, analytical and critical thinking skills 

• Substantial understanding of processes and equipment used in assigned work 

• Good leadership skills and ability to influence change 

• Knowledge of and adherence to Quality systems 

• Strict attention to detail 

• Ability to interact professionally with all organizational levels 

• Ability to manage competing priorities in a fast paced environment 

• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects 

• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.