Senior Quality Process Engineer — Onsite in Chandler

Regulatory Jobs; Chandler (AZ); Vor Ort; USD 89.000 - 149.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality concepts

CAPA

Audits

Statistics

Risk management

Communication

Project management

Ausbildung

Bachelor of Science in engineering

Jobbeschreibung

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