Staff Engineer Quality Process

About the role

Stryker is hiring a Staff Quality Process Engineer, an onsite position in Chandler, Arizona. The role provides quality engineering leadership and direction in quality assurance, control and preventative activities, with a focus on continuous improvement of products and processes. It also involves mentoring and technical direction across several areas of expertise.

Key responsibilities

• Work with operations and business functions to ensure quality performance of products and processes, and with customers, sales/marketing/field personnel and cross-functional teams to address top quality issues.
• Mentor others, oversee and approve NC/CAPA, and act as a high-level expert in problem-solving and root-cause analysis.
• Lead the development and improvement of manufacturing processes for existing products, and lead investigations during concession management.
• Review and approve change management activities, interpret KPI trends and drive continuous improvement.
• Advocate Human Factor practices, and act as subject matter expert in risk management.
• Provide technical direction on optimizing inspection methods and sampling, using statistical methods.
• Take part in internal and external audits with regulators, and help develop validation strategies and support manufacturing transfers to other plants.
• Initiate, contain internally and support ship and product holds for potential product escapes.

Required profile

• Bachelor of Science in engineering or a related discipline.
• At least 5 years of experience, including previous medical industry experience.
• Prior product transfer experience.
• Ability to manage multiple tasks, work independently and in cross-functional teams, and handle compliance-risk situations.
• Preferred: MS, CQE or CRE, Six Sigma Green or Black Belt, experience launching new production lines, and experience with regulatory agencies such as the FDA.

Required skills

• Understanding of US and international medical device regulations.
• Familiarity with ISO 13485, GDP and GMP.
• Strong knowledge of quality concepts such as risk management, CAPA, audits and statistics.

Pay range in the United States: $89,300 - $148,800 per year. About 10% travel may be required.