Staff Engineer Quality Process

Regulatory Jobs; Chandler (AZ); On-site; USD 89,000 - 149,000; Full time

Job summary

Stryker Corporation in Chandler, Arizona seeks a Staff Quality Process Engineer to provide quality engineering leadership in QA, QC and preventative activities, focusing on continuous improvement of products and processes. You will mentor teams, ensure compliance with US and international medical device regulations, and drive initiatives to enhance quality for customers.

You will collaborate with operations, sales and cross-functional teams to resolve top quality issues, manage NC/CAPA, and lead

Qualifications

• Bachelor of Science in engineering or related discipline.
• 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.

Responsibilities

• Work closely with operations to ensure quality performance of product and processes.
• Address top quality issues with customers, sales/marketing/field personnel, and cross-functional teams.
• 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.

Skills

Quality concepts

CAPA

Audits

Statistics

Risk management

Communication

Project management

Education

Bachelor of Science in engineering

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

• $89,300 - $148,800 USD Annual

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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.