Staff Quality Engineer - 3PL

Work Flexibility: Hybrid or Onsite

Stryker is hiring a Staff 3PL Quality Engineer in Portage, Michigan to support our Global Logistics Operations Quality Assurance Team (GLO QA), working within our Central Distribution Centers!

In this role, you will provide quality leadership and technical guidance on 3PL Quality within the distribution centers and other business functions at local level, advocating and leading the execution of initiatives & projects to enhance quality performance. You will mentor teams, provide technical direction, and ensure compliance with regulations and standards. Additionally, you will implement a unified quality approach with 3PL partners to deliver high-quality products and services that meet Stryker’s standards, while building cross-functional relationships to develop best practices.

Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility. You should be comfortable working three days onsite.

What You Will Do:

• Work closely with business functions assess, provide oversight and direction on quality performance of product and processes.

• Mentor and provide oversight on quality topics, including NC & CAPA, problem-solving, and root cause analysis, with expertise across several areas.

• Lead quality initiatives and projects locally, and act as a recognized process owner in areas such as risk management, concessions, change management, lean, six sigma, CAPA, statistics, validation, and inspection processes.

• Provide input on local processes and participate in review & discussion boards

• Analyze KPI trends, take action when necessary, and drive continuous improvement.

• Contribute to the development of quality strategies

• Support manufacturing transfers, leading quality activities.

• Manage product holds, shipments, and potential product escapes, and resolve supplier quality issues impacting daily operations.

• Oversee and improve supplier quality tools and processes, and train suppliers effectively.

• Own site quality performance, including KPIs, and participate in supplier performance reviews.

• Lead supplier containment and corrective actions while ensuring compliance with Supplier Control activities.

What You Will Need:

Required:

• Bachelor’s degree required. Preferred to be in Science or Engineering or equivalent

• 4+ years or work experience in a quality discipline.

• Regulated industry experience required.

Preferred Qualifications:

• Medical Device/Bio-tech industry experience preferred.

• Familiarity with ISO 13485, GDP, GMP and US/International Medical Device Regulations.

• Strong knowledge of Quality Concepts (e.g., Risk Management, CAPA, Audits, Statistics).

• Experience with one or more quality tools, such as Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, and/or Lean Manufacturing

• Six Sigma Green or Black belt preferred.

• Experience with regulatory agencies (FDA, BSI, etc.) desired.

• Excellent communication, project management, and influencing skills, with the ability to manage multiple tasks and represent the Quality function across teams.

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.