Staff Quality Process Engineer — Onsite Chandler

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

Job summary

Stryker seeks a Staff Quality Process Engineer to provide quality engineering leadership in assurance, control, and preventative activities, driving continuous improvement for products and processes. Onsite in Chandler, AZ, you will mentor teams, oversee NC/CAPA, and lead investigations and validation strategies.

Requirements include a BS in engineering, 5+ years in medical devices, and strong knowledge of ISO 13485, GMP, and Quality concepts.

Qualifications

• 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.

Responsibilities

• 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.

Skills

CAPA

Audits

Risk Management

Statistics

Project Management

Communication skills

Education

BS in Engineering

Job description

Stryker seeks a Staff Quality Process Engineer to provide quality engineering leadership in assurance, control, and preventative activities, driving continuous improvement for products and processes. Onsite in Chandler, AZ, you will mentor teams, oversee NC/CAPA, and lead investigations and validation strategies.

Requirements include a BS in engineering, 5+ years in medical devices, and strong knowledge of ISO 13485, GMP, and Quality concepts.