Senior Engineer, Quality Assurance

Work Flexibility: Hybrid

• Passionate & Goal-oriented Engineers: Passion for excellence in technology. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
• Analytical problem solvers:  People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers:  People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Self-Driven Curious learners:  People who take initiative and hold themselves accountable. People who seek out for cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.
• Effective communicators: People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

What you will do

At Stryker, quality is first in everything we do. We are driven to make healthcare better for our customers by providing innovative products and services that meet regulatory requirements through our effective quality system. As part Quality Assurance, engineers maintain our brand of high-quality products and cross functional collaboration. ​​​

A Senior Quality Engineer will provide support for manufacturing and lab systems with a focus on sustaining products. Manages the execution and changes lab owned software systems, internal manufacturing and external suppliers while ensuring compliance to regulations and standards.  This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulation and standards. 

Responsibilities:

• Supports laboratory computer system life cycle management including but not limited to procedures, validation documents, configuration, periodic compliance reviews, and change implementation decision task (CIDT). 

  
  

• Develop and execute laboratory computer system validation documents in accordance with company and regulatory requirements.

  
  

• Supports changes in the manufacturing and lab environment through the development and approval of equipment validation/qualification and MSAs as needed.

  
  

• Collaborates with local cross functional team including quality counterparts, manufacturing, QC and engineering. 

  
  

• Executes internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes. 

  
  

• Responsible for NCs and CAPAs in area of responsibility.

  
  

• Lead basic Root Cause Investigation events, such as CAPAs in area of responsibility

  
  

• Can independently create and approve records containing technical writing.

  
  

What you need:

• ​ B. Tech/ B.S. in engineering/ biomedical/ mechanical/ scientific or related field with 6+ years of working experience.

  
  

• Experience working in a regulated industry, preference given to Medical Device/ pharmaceutical experience.

  
  

• Experience with Computer Software Validation

  
  

• Strong written and oral communication skills. 

  
  

Technical Competencies

• Quality Processes/ Validation - Working knowledge of basic and advanced Quality tools such as; Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, MSA & Equipment Qualification.