Senior Quality Engineer NPI

Redmond, WA - USA

Monthly Salary: $ 77700 - 168400

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Onsite

Senior Quality Engineer - New Product Introduction
Redmond WA

Join a team that brings lifechanging medical technologies from concept to patients around the world. As a Senior Quality Engineer - NPI you will play a critical role in ensuring new products and processes are designed transferred and launched with the highest standards of quality and reliability. This is an exciting opportunity to influence how products are built validated and scaled - right from the start.

What You Will Do

Execute quality assurance activities during design transfer to ensure new products and processes meet defined quality regulatory and manufacturing requirements.
Evaluate and mitigate manufacturing and process risks by developing and maintaining robust process Failure Modes and Effects Analyses across the full manufacturing lifecycle.
Develop and implement efficient inspection strategies including sampling plans First Article Inspection approaches and measurement system analysis to ensure repeatable and scalable inspections.
Support and approve validation activities by contributing to the development execution and review of validation protocols and reports including sterilization validation where required.
Apply statistical and riskbased techniques to build predictive transferable quality systems that support stable production and successful launches.
Support nonconformance and corrective and preventive action activities related to new products ensuring timely root cause analysis and sustainable solutions.
Partner with supplier quality and sourcing teams to support supplier selection qualification validation and production part approval activities.
Represent quality assurance in design reviews and design transfer planning ensuring lessons learned are captured and transferred to sustaining quality teams postlaunch.

What You Will Need

Required Qualifications

Bachelors degree in Engineering or a related technical discipline.
2 years of experience in a regulated manufacturing environment.
Experience supporting quality activities for new product or process introductions.
Proficiency in riskbased and statistical quality techniques including process risk analysis sampling plans process capability and measurement system analysis.

Preferred Qualifications

Certification as a Certified Quality Engineer or equivalent coursework or experience.
Working knowledge of quality system regulations and standards such as ISO 13485 and FDA Quality System Regulation.
Lean Six Sigma training or certification.
Experience with medical device manufacturing processes and validation activities.

$77700.00 - 168400.00 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.

Required Experience:

Senior IC

Work Flexibility: OnsiteSenior Quality Engineer - New Product Introduction Redmond WAJoin a team that brings lifechanging medical technologies from concept to patients around the world. As a Senior Quality Engineer - NPI you will play a critical role in ensuring new products and processes are design...

Work Flexibility: Onsite

Senior Quality Engineer - New Product Introduction
Redmond WA

What You Will Do

Execute quality assurance activities during design transfer to ensure new products and processes meet defined quality regulatory and manufacturing requirements.
Evaluate and mitigate manufacturing and process risks by developing and maintaining robust process Failure Modes and Effects Analyses across the full manufacturing lifecycle.
Develop and implement efficient inspection strategies including sampling plans First Article Inspection approaches and measurement system analysis to ensure repeatable and scalable inspections.
Support and approve validation activities by contributing to the development execution and review of validation protocols and reports including sterilization validation where required.
Apply statistical and riskbased techniques to build predictive transferable quality systems that support stable production and successful launches.
Support nonconformance and corrective and preventive action activities related to new products ensuring timely root cause analysis and sustainable solutions.
Partner with supplier quality and sourcing teams to support supplier selection qualification validation and production part approval activities.
Represent quality assurance in design reviews and design transfer planning ensuring lessons learned are captured and transferred to sustaining quality teams postlaunch.

What You Will Need

Required Qualifications

Bachelors degree in Engineering or a related technical discipline.
2 years of experience in a regulated manufacturing environment.
Experience supporting quality activities for new product or process introductions.
Proficiency in riskbased and statistical quality techniques including process risk analysis sampling plans process capability and measurement system analysis.

Preferred Qualifications

Certification as a Certified Quality Engineer or equivalent coursework or experience.
Working knowledge of quality system regulations and standards such as ISO 13485 and FDA Quality System Regulation.
Lean Six Sigma training or certification.
Experience with medical device manufacturing processes and validation activities.

$77700.00 - 168400.00 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.

Travel Percentage: 10%

Required Experience:

Senior IC

Key Skills

Quality Assurance
Six Sigma
Design Controls
FDA Regulations
ISO 9001
Minitab
Root cause Analysis
ISO 13485
Quality Systems
Quality Management
As9100
Manufacturing

Apply Now

About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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