New Product Introduction Quality Engineer in Tijuana at Stryker Corporation

Date Posted: 8/1/2019

Job Snapshot

Job Description

NPI Quality Engineer at Stryker

Why a Career at Stryker?

  • A career with Stryker will push you and challenge you, providing growth opportunities and the prospect to advance your career. We only hire the best and you will be surrounded by others who are driven for success, giving you the support to reach your full potential.
  • Stryker is a great place to work - but don't just take our word for it, find out for yourself:

What you will do?

The NPI Quality Engineer develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. While not all encompassing, this role’s primary activities can be grouped into three main areas:  

Collect, interpret, and determine the root cause of failures.

  • Stop further processing in the event of encountering non-conforming product condition.
  • Develop the quality report.
  • Develop and communicate the reliability and warranty goal to the Operation Unit assigned for new products.
  • Resolve testing corrective actions and determine the necessary corrective and preventative actions

Identify and track potential product and process risks.

  • Conduct design reviews and track all findings.
  • Conduct risk analyses and track all findings.
  • Release customer preference test and customer confirmation test units for shipment.
  • Develop the risk management portfolio.
  • Conduct audits as specified by the divisional schedule and as determined by new product development needs.
  • Develop quality-related specifications and tests for software projects.
  • Write safety, durability, craftsmanship, and reliability design input specifications from Quality report, design reviews, risk analyses, and customer research.
  • Develop statistical rationale for testing.
  • Develop the rationale for validation sample size, duration, and number of locations.

Assist and develop process controls

  • Implement internal detective process controls.
  • Specify which preventative and detective controls are required, and communicate to vendors, internal/ external clients.
  • Verify gage repeatability, reproducibility, and accuracy, and address deficiencies.
  • Develop and document the inspection methods.
  • Develop the budget and schedule for process controls.
  • Validate vendor-implemented process controls.
  • Perform tool validation for off-the-shelf and custom test fixtures for software projects.
  • Perform validation of software-controlled production test system / equipment for software projects.

Prepare product and operations for transition

  • Train quality assurance engineers and inspectors.
  • Handle quality assurance engineering responsibilities after launch.
  • Prepare risk management portfolio for long term maintenance by the Quality Engineer.

Advanced Responsibilities

  • Has some latitude for unrelieved action or decisions.
  • Usually works with minimum supervision, conferring with superiors on unusual matters.
  • Viewed as a team resource in the area of expertise.
  • Commit to environmental policy.
  • May train others in quality assurance/GMP related topics.
  • Continuously fully comply with all quality regulatory requirements.

Who we are looking for

We are looking for energetic and inspiring professionals with demonstrated quality assurance experience, combined with some of the following traits:

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
  • Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

What you need?

Basic Qualifications

  • Bachelor’s degree in engineering or related discipline.
  • Minimum 3 to 5 years of Quality Assurance experience.
  • Knowledgeable in FDA-QSR and ISO guidelines.
  • Strong Statistical knowledge (SPC, DOE, CPk, etcetera).

Preferred Qualifications

  • ASQ-CQE or CQA desired.
  • Six Sigma certification desired.

Work From Home: No

Travel Percentage: Up to 25%

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