**Work Flexibility:** Hybrid or Onsite
Stryker is hiring an Engineer, Post Market Quality inPortage, MI supporting the Ortho Tech division to provide quality engineering leadership and support across quality assurance, quality control, and preventive quality activities, with a strong focus on driving continuous improvement in products, processes, and overall quality system effectiveness. Lead and champion quality initiatives and cross-functional projects to enhance business performance and customer satisfaction while ensuring compliance with applicable regulatory requirements, industry standards, and company policies.
Work Flexibility: Hybrid: candidates must reside within commuting distance of Portage, MI and be able to work onsite several days per week.
What you will do
- Collaborate with customers, commercial teams, and cross-functional partners to support the investigation and resolution of product and process quality issues.
- Assist with Nonconformance (NC) and CAPA activities, utilizing structured problem-solving and root cause analysis tools to identify and implement corrective actions.
- Support complaint investigations, post-market quality activities, and product field actions while ensuring compliance with quality system and regulatory requirements.
- Monitor and analyze quality metrics and KPIs to identify trends, support continuous improvement efforts, and drive data-based decision-making.
- Apply quality engineering principles, risk management concepts, Human Factors considerations, and basic statistical methods to support product and process quality.
- Participate in internal audits and support external audit and inspection readiness activities by maintaining documentation and providing quality-related information.
- Assist with quality containment activities, including product holds, investigations, and assessments related to potential product quality concerns.
- Support continuous improvement initiatives and collaborate with experienced quality professionals to develop knowledge of quality systems, regulatory requirements, and industry best practices.
What you need
Required Qualifications
- Bachelor’s degree in engineering related discipline.
Preferred Qualifications
- Experience in quality engineering, post-market quality, or regulatory compliance, with knowledge of quality systems and concepts such as Risk Management, CAPA, Audits, and Statistical Analysis.
- Experience working with regulatory authorities such as the FDA, MoH, TUV, etc.
- Experience conducting risk analysis, root cause investigations, and statistical data analysis, including interpreting results to support quality improvements and data-driven decision-making.
