Staff Quality Process Engineer - Onsite Chandler

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

Job summary

Stryker Group is seeking a Staff Quality Process Engineer to provide quality engineering leadership in QA, QC, and preventative activities at our Chandler, Arizona site. You will mentor teams, lead risk management initiatives, and ensure compliance with US and international medical device regulations.

This onsite role requires extensive experience in quality concepts, CAPA, and audits, with a focus on process improvement and supplier/customer collaboration. Travel may be required.

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.
• Previous 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.

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.
• Mentor and provide oversight of NC/CAPA, root-cause analysis, and problem-solving activities.
• Develop and improve manufacturing processes for existing products.
• Lead investigations during concession management and audit processes.
• Review and approve change management activities and drive effectiveness.
• Interpret KPI trends and drive continuous improvement.

Skills

Quality concepts

CAPA

Audits

Statistics

Project management

Communication

Influencing skills

Risk management

Education

Bachelor of Science in engineering

MS, CQE, or CRE

Job description

Stryker Group is seeking a Staff Quality Process Engineer to provide quality engineering leadership in QA, QC, and preventative activities at our Chandler, Arizona site. You will mentor teams, lead risk management initiatives, and ensure compliance with US and international medical device regulations.

This onsite role requires extensive experience in quality concepts, CAPA, and audits, with a focus on process improvement and supplier/customer collaboration. Travel may be required.