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Senior Quality Assurance Engineer

2 months ago

Arlington, Tennessee, United States Stryker Full time

Work Flexibility: Onsite

Stryker is seeking a Senior Quality Assurance Engineer to contribute to our Trauma and Extremities division. In this position, you will deliver quality engineering support focused on quality assurance, control, and preventative measures, emphasizing the continuous enhancement of internal products and processes.

Who we are looking for:

  • Collaborative team players. Individuals who cultivate and utilize cross-functional relationships to merge ideas, data, and insights, driving ongoing improvements across functions.
  • Analytical thinkers. Professionals who delve deeper than mere fixes to uncover root causes, assess optimal solutions, and propose comprehensive enhancements to avert future challenges.
  • Committed achievers. People who excel in a dynamic environment and are determined to ensure that projects are completed in compliance with regulations and expectations.
Key Responsibilities:
  • Address supplier quality challenges affecting daily operations. Champion and spearhead initiatives and projects aimed at improving quality performance within the organization and for our clients.
  • Guide and provide technical mentorship across various areas of expertise.
  • Ensure adherence to regulations and standards.
  • Collaborate closely with operations and business functions to guarantee quality performance of products and processes.
  • Work in partnership with Divisional QA, cross-functional teams, and suppliers to tackle major quality concerns.
  • Manage identified internal and supplier non-conformances, ensuring timely resolution.
  • Oversee or assist with internal CAPAs, ensuring prompt root cause analysis, implementation, and closure.
  • Assess non-conforming products within MRB, issuing NCs as necessary.
  • Engage with suppliers regarding non-conformances, escalating corrective action requests as needed.
  • Participate in the development and enhancement of internal manufacturing processes for existing products.
  • Conduct thorough evaluations of internal and supplier proposed change management activities.
  • Execute PPAP activities for supplier modifications.
  • Contribute to and may lead the creation and/or review of new or revised procedures.
  • Maintain KPIs for monitoring process and product quality, performing analyses, and interpreting trends to identify and implement necessary actions.
  • Assist in the execution and analysis of manufacturing-related complaints and product field actions.
  • Promote and drive Human Factor practices, demonstrating familiarity with the science of Human Factor identification, reduction, and mitigation.
  • Collaborate with relevant stakeholders to identify and pursue opportunities for supplier part certification.
  • Develop a solid understanding of risk management practices and concepts, applying this knowledge to manufacturing operations.
  • Support the creation and upkeep of inspection methods and sampling.
  • Utilize statistical analysis methods and process control in current operations.
  • Engage in internal and external audits, providing subject matter expertise.
  • Assist in the development and review of process and equipment validation/qualification and MSA of internal processes.
  • Fulfill internal quality deliverables related to engineering changes, manufacturing transfers, and supplier-initiated changes.
  • Support manufacturing transfers to/from other facilities, executing relevant quality activities.
  • Be responsible for initiating, containing internally, and supporting Commercial Holds for potential product escapes.
  • Drive continuous improvement initiatives to minimize manufacturing defects.
  • Provide leadership and subject matter expertise in QA activities across the site.
Qualifications:

Required:
  • Bachelor's degree in a scientific, engineering, or related field.
  • 4+ years of experience in quality, engineering, manufacturing, and/or operations within a highly regulated industry.
Preferred:
  • Familiarity with ISO14971 and ICHQ9 risk management standards and guidelines.
  • Experience in compliance risk situations.
  • Strong quality background with CQE and/or Six Sigma Green or Blackbelt preferred.
  • Expertise in Quality concepts (e.g., Risk Management, CAPA, Audits, Statistics, DMAIC, DFSS).
  • Excellent interpersonal, written, and oral communication skills, along with negotiation abilities.
Travel Percentage: 10%

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.