Overview
Senior Quality Engineer Jobs in Arlington, Washington, USA at Stryker Group
Stryker is hiring a Senior Quality Engineer to support our Global Quality Operations team, working within our Trauma & Extremities business in Arlington, TN! As a Senior Quality Engineer, you will provide quality leadership and direction in quality assurance, control, and preventative activities within operations with a focus on preventative measures and continuous improvement of products and processes. You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business.
What you will do:
Provide engineering expertise in quality assurance, control, and prevention, driving continuous improvement in internal products and processes.
Address and resolve supplier quality issues affecting daily operations, ensuring minimal disruption and compliance with standards.
Advocate for and lead projects that enhance quality performance for internal processes and customer satisfaction.
Ensure alignment with industry regulations and standards while maintaining high-quality manufacturing practices.
Work with Divisional QA, suppliers, and cross-functional teams to resolve top quality issues, managing internal and supplier non-conformances and CAPAs.
Maintain KPIs, analyze trends, and implement corrective actions to monitor and improve process and product quality.
Engage in optimizing internal manufacturing processes, including process and equipment validation/qualification and MSA.
Support analysis of manufacturing-related complaints and product field actions while driving initiatives to reduce defects and enhance overall site QA activities.
What you will need:
Basic Qualifications:
Bachelors degree in a science or engineering related discipline.
Minimum of 2+ years of experience as an Engineer in the areas of quality, manufacturing or operations within a highly regulated industry in following cGMP and GDP regulations.
Preferred Qualifications:
Understanding of US and International Medical Device Regulations, with familiarity in ISO 13485 with experience in a medical device, pharmaceutical, or biopharmaceutical industry.
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
Six Sigma Green or Black belt preferred.
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Title: Senior Quality Engineer
Company: Stryker Group
Location: Arlington, Washington, USA
Category: Quality Assurance – QA/QC (Quality Engineering), Engineering (Quality Engineering)
