Advanced Quality Engineer

Description Stryker is an exceptional company with exceptional people who deliver exceptional results. We have differentiated ourselves by advancing meaningful innovations, creating cost-effective solutions for and improving the lives of our global customers and patients. As a winner of the 2007 and 2008 Gallup Great Workplace Award, we have demonstrated that Stryker has one of the most productive and engaged workforces in the world. Our exceptional results fuel ongoing opportunities for Stryker employees to build outstanding careers and to develop and grow both personally and professionally. Our work environment attracts many different kinds of talented and driven people who love to win and serve others. We always put quality first. We hold ourselves accountable to reach or exceed our goals and continually improve everything we do. These attributes are shared by the employees that make up Stryker. They are the things that bring us together and serve as the foundation of all we do. And they are the enablers of both our past and future success.

Stryker is one of the world's leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. For more information about Stryker, please visit the company web site at: http://www.stryker.com.

GENERAL DESCRIPTION:
Responsible for the identification of potential failure modes and risks, and the development of quality assurance practices and controls in new product development. Knows and applies the fundamental and some advanced concepts, practices and procedures of the advanced quality specialization.

ESSENTIAL FUNCTIONS:
Collect, interpret, and determine the root cause of failures

Develop the quality report

Develop and communicate the reliability and warranty goal to Center 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

Manage and track all software issues*

Participate in software requirement specification and software design document reviews, and code reviews as needed*

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

Conduct software quality assurance plan audits to verify development practices conform to procedures*

Review software configuration management to verify its practices conform to procedures*

Develop quality-related specifications and tests

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

Create and maintain software traceability matrix to track all requirements to closure*

Develop and maintain black box test scripts*

Assist and develop process controls

Implement internal detective process controls

Specify which preventative and detective controls are required, and communicate to vendors

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 software first article inspection*

Perform tool validation for off-the-shelf and custom test fixtures*

Perform validation of software controlled production test system / equipment*

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 QAE

Advanced Responsibilities

Has some latitude for unreviewed action or decisions.

Usually works with minimum supervision, conferring with superiors on unusual matters.

Viewed as a team resource in the area of expertise.

These items pertain to software projects.

QUALIFICATIONS:

Bachelors Degree in science or engineering

Minimum of 2-3 years experience in field of specialization

Achieved a advanced (learning) level of industry knowledge

Competent with Microsoft Office (Outlook, Excel, Word, etc.)

Must possess excellent oral and written communication skills

Ability to solve problems in a high stress situation

Possess attention to detail

Eagerness to assist internal and external customers

Manage projects in a timely manner

Ability to conduct and document technical investigation

The following experiences/skill sets are highly desirable:

ISO 13485 and ISO 14971

Industrial statistical techniques

Development and implementation of design and process controls

GD&T

Six Sigma Black Belt Certification preferred

Experience with SPC

Familiarity with FDA Guidance on Design Controls and CAPA Methodologies

Familiarity with the Quality System Regulation 21 CFR Part 820, and CGMP

Work experience with a medical device manufacturer preferred

Experience with Design for Manufacturing

Manufacturing Experience

Knowledge of Poke Yoke (Error-Proofing) techniques

510(k) submission experience

B.S. Mechanical Engineering Degree, M.S. advanced degree desired

New Product development/R&D experience


PHYSICAL/SAFETY REQUIREMENTS:

May involve prolonged periods of stooping, kneeling, crouching, bending, sitting, standing, and/or crawling as appropriate.

May be required to move equipment up to 50 pounds, reach, push, or pull in order to accomplish job accountabilities.

Coordination of eye, hand, and/or foot movement with an ability to grasp by hand and meet cognitive demands to include visual and auditory discrimination/memory, reading ability, and memory retention ability.

Requires use of safety glasses in designated areas.

Closed-toe shoes must be worn on the production floor; safety shoes are recommended.

QUALIFICATIONS:

Bachelors Degree in science or engineering

Minimum of 2-3 years experience in field of specialization

Achieved a advanced (learning) level of industry knowledge

Competent with Microsoft Office (Outlook, Excel, Word, etc.)

Must possess excellent oral and written communication skills

Ability to solve problems in a high stress situation

Possess attention to detail

Eagerness to assist internal and external customers

Manage projects in a timely manner

Ability to conduct and document technical investigation

The following experiences/skill sets are highly desirable:

ISO 13485 and ISO 14971

Industrial statistical techniques

Development and implementation of design and process controls

GD&T

PHYSICAL/SAFETY REQUIREMENTS:

May involve prolonged periods of stooping, kneeling, crouching, bending, sitting, standing, and/or crawling as appropriate.

May be required to move equipment up to 50 pounds, reach, push, or pull in order to accomplish job accountabilities.

Coordination of eye, hand, and/or foot movement with an ability to grasp by hand and meet cognitive demands to include visual and auditory discrimination/memory, reading ability, and memory retention ability.

Requires use of safety glasses in designated areas.

Closed-toe shoes must be worn on the production floor; safety shoes are recommended.

Stryker is an equal employment opportunity/affirmative action employer committed to hiring a diverse workforce.

To read more about Stryker, please visit our website at www.stryker.jobs.