Staff Engineer Quality Process

Hardware FYI; Chandler (AZ); Hybrid; USD 89,000 - 149,000; Full time

Job summary

Stryker Corporation is seeking a Staff Quality Process Engineer for onsite leadership in quality assurance, control, and preventive activities in Chandler, Arizona. The role emphasizes continuous improvement of products and processes and requires mentoring across multiple domains.

You will work with operations and cross-functional teams to address top quality issues, lead NC/CAPA, and drive risk-based decisions.

Qualifications

• Bachelor's degree in engineering or related field.
• 5+ years of experience in medical device quality.
• Experience with US and international medical device regulations.
• Product transfer experience.
• Knowledge of ISO 13485, GDP, GMP.
• Strong communication and project management skills.

Responsibilities

• Collaborate with operations to ensure quality performance of products and processes.
• Lead investigations and CAPA activities, and drive corrective actions.
• Mentor and provide technical direction in quality topics and problem-solving.
• Oversee change management and validation activities for products and processes.
• Support manufacturing transfers and risk management practices.

Skills

CAPA

Audits

Statistics

Risk management

Quality leadership

Project management

Cross-functional

Education

BSc Engineering

CQE

CRE

Job description

Work Flexibility: Onsite

The Staff Quality Process Engineer will provide quality engineering leadership and direction in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance with regulations and standards. This role is Onsite in Chandler, Arizona.

What you will do

• Work closely with operations and the business functions to ensure quality performance of product and processes.

• Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.

• Mentors, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities.

• Initiates and leads in the development and improvement of the manufacturing processes for existing products.

• Oversight and leads investigations during concession management.

• Review and approval of change management activities, challenges effectiveness and drives strong review.

• Interpret KPI trends, drive continuous improvement process.

• Advocate of Human Factor practices, proficiency in the science of identification of mitigation.

• Subject matter expert in risk management practices and concepts.

• Develop and provide input by identifying opportunities and weaknesses.

• Proficiency in and provides technical direction in optimization of inspection methods and sampling.

• High proficiency in statistical methods and application.

• Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business.

• May manage audit logistics and/or preparation.

• Aids in the development of validation strategies for existing products.

• Support manufacturing transfers to other plants/facilities, leading quality activities.

• Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.

• Coach and mentor others in quality topics and activities.

• Some travel may be required.

What you need

• Bachelor of Science in engineering or related discipline.

• Minimum of 5+ years' experience.

• Previous medical industry experience required.

• Understanding of US and International Medical Device Regulations.

• Pervious product transfer experience required.

• Familiarity with ISO 13485, GDP, GMP required.

• Strong knowledge of Quality Concepts ( e.g. Risk Management, CAPA, Audits, Statistics).

• Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.

Preferred

• MS, CQE, or CRE.

• Six Sigma Green or Black belt.

• Experience in launching new production lines desired.

• Experience in interacting with regulatory agencies (FDA, MoH, TUV; etc.) desired.

• Ability to represent Quality function within and across project teams.

• Strong interpersonal skills, written, oral communication and negotiations skills.

• Strong in critical thinking and "outside the box" thinking.

• Highly developed problem-solving skills.

• Strong analytical skills.

• Demonstrated ability to successfully manage and complete projects in a matrix organization.

• Demonstrated ability to work independently and as part of cross-functional teams.

• Experience in working in a compliance risk situation.

United States of America Pay Ranges:

• USN: $89,300 - $148,800 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

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 contractor’s legal duty to furnish information.