Job Information
Corza Medical Design Quality Engineer - Hybrid in Chula Vista, California
Design Quality Engineer - Hybrid
Location of Work Chula Vista, CA; San Diego, CA; Tijuana, Mexico
Employment Type Full Time Employee
Job Description
Our mission
At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way.
Our brand promise
We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.
Remarkable service: A seamless, personal process designed around you and your needs.
Trusted performance: Our product family is the result of years of experience championing surgeons and listening to their expertise.
Outstanding value: No matter the surgical specialty, we deliver quality products for all markets.
Our people promise
Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.
This is a hybrid role that is required to move in Tijuana, Mexico 3-4 days a week and 1-2 days remotely
Job Purpose Summary
As the Design Quality Engineer , you’ll be responsible for developing and maintaining quality engineering methodologies in pursuit of delivering products that are safe and effective.
What you will do
Guide the quality assurance efforts in the design and development of technical transfers
Appropriately document experiment plans and results, including protocol writing and reports
Lead the investigation, resolution and prevention of product and process nonconformance's (e.g. CAPAs/HHEs)
Participate in or lead teams in supporting quality disciplines, decisions, and practices
Support design reviews and transfers, providing inputs on quality requirements, ensuring gap analysis and supporting risk mitigation strategies
Adept knowledge on Medical Device waterfall gated process to be able to translate Customer/Market requirements (User Needs and intended use), Product Performance (Design Inputs, product requirements), Product Design (Design Outputs, device specifications, design specifications, design validations) and process Controls (Production and supplier controls).
Provide guidance and support to other engineers to ensure quality integrity
Support the development, implement various product, and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
Work with design engineering in the completion of product verification and validation
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Design and conduct experiments for process optimization and/or improvement
What you will need (job requirements)
Bachelor’s degree in Engineering or equivalent education and experience
3+ years of experience working in a Design Quality Engineering role within a medical device industry
Strong knowledge of quality management systems
Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities)
Strong Knowledge of statistical analysis tools and their use in product design and manufacturing.
Six Sigma training is a must.
Experience in creating design control documentation during the whole lifecycle of the development process
Experience with previous transfer of products from design to volume manufacturing
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Strong project management and leadership skills, including the demonstrated ability to lead project teams and resolve quality-related issues in a timely and effective manner
Advanced computer skills, including statistical/data analysis and report writing skills
Experience implementing various product and process improvement methodologies
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Fluent in Spanish and English required
What we value
Customer First - We deliver extraordinary experiences.
Accountability - We do what we say.
Integrity - We do what is right.
Inspired - We love what we do.
One Global Team -We before me, always.
Join us today and Excel@Corza !
Corza Medical offers a competitive benefits package including medical, 401K, vacation and sick time, paternal leave and other benefits.
Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.