Related content
Loading...
Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture. We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits
Job description
Stryker is hiring a Senior Quality Engineer for our Global Quality Operations where you'll play a key role in driving quality excellence and delivering impactful results. We’re looking for a passionate advocate of quality and lean methodologies—someone who thrives in a fast-paced environment, takes initiative, and communicates effectively across all levels of the organization. If you're a self-directed Quality professional committed to ensuring superior product quality for patients and customers, we want to hear from you.
What you will do:
Operate independently within the Quality Operations team, ensuring compliance and excellence in quality-related activities across products and processes.
Collaborate with cross-functional teams to drive quality performance, lead manufacturing process improvements, and support new product introductions.
Manages and provides oversight, approval, and mentorship in nonconformances and corrective action preventative actions (NC/CAPA) processes, root cause analysis, and problem-solving initiatives.
Review and approve change management, validation, and qualification activities for processes and equipment.
Monitor and analyze quality KPIs, identify trends, and implement corrective actions to maintain process integrity.
Apply advanced risk management and Human Factors principles to proactively identify and mitigate quality risks.
Optimize inspection methods, support First Article Inspections, and apply statistical tools to enhance product quality.
Represent Quality in internal and external audits, lead quality efforts in manufacturing transfers, and manage product holds and potential escapes.
Support the execution and analysis of manufacturing complaints and product field actions.
What you need:
Required Qualifications:
Bachelor’s Degree in a Science or Engineering related discipline.
Minimum of 2+ years of experience as an Engineer working within quality, manufacturing, or new product development.
Experience in adhering to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) to ensure compliance with regulatory standards.
Preferred Qualifications:
Proficient in medical device manufacturing processes with a strong understanding of ISO 13485 and industry standards.
Certification in one or more of the following: Certified Quality Engineer (CQE), Lead Auditor and/or Lean Six Sigma.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Apply Now