Quality Technician

1 month ago

Austin, Texas, United States Smith & Nephew Full time
Job Title: Sr. Quality Technician

At Smith+Nephew, we are committed to delivering high-quality products that meet the needs of our customers. We are seeking a highly skilled and experienced Sr. Quality Technician to join our team.

Key Responsibilities:
  • Support the operation of Quality Management and Quality Engineering's day-to-day efforts to ensure product quality and patient safety.
  • Process Monitoring: Conduct environmental monitoring and other quality activities for the site's cleanroom.
  • Coordinate and assist with product testing needs at direction of engineering and Quality Management.
  • Track and trend process monitoring results.
  • Returned Device Analysis: Manage devices returned associated with complaints, including receiving, handling, and visual / functional analysis.
  • Enter results of analysis into eQMS complaints system.
  • Serve as point of contact for Global Complaints organization in coordination of device return.
  • Nonconformance Administration: Verify and coordinate nonconformance system tasks, including disposition executions.
  • Containment of impacted product onsite and communication with vendors regarding potentially impacted product.
  • Prepare material for weekly nonconformance / MRB meetings.
  • Manage work-in-progress hold process.
  • Other Activities as Directed: Support Supplier Quality, New Product Quality, and operations as directed.
  • Backup for calibration technical responsibilities.
  • Support Change Control process through generation of change requests, creation of redline drafts, and coordination with Quality Systems.
  • Gather data to facilitate quality metric reporting.
  • Create and / or revise Inspection Plans and support execution of Gage R&Rs.
Requirements:
  • High school diploma or GED required. Associate degree or higher level of post-secondary education in an engineering or technical discipline preferred.
  • Certification from the American Society of Quality (ASQ) preferred, such as Ceritified Quality Technician (CQT), Certified Calibration Technician (CCT), Certified Quality Inspector (CQI), Certified Quality Engineer (CQE), Certified Quality Improvement Associate (CQIA), Certified Quality Process Analyst (CQPA), Certified Reliability Engineer (CRE), or equivalent.
  • Minimum 5 years of work experience in related field (prior experience as a Quality Inspector or Technician in a manufacturing environment preferred).
  • Effective Technical Writing skills and experience working within various software systems (Word, Excel, etc.). Prior experience in CAD, PLM, eQMS, and ERP systems preferred.
  • Strong understanding of good manufacturing practices (GMP) and good documentation practices (GDP). Familiarity with ISO 13485.
  • Detail-oriented with a commitment to accuracy and precision.
  • Effective communication skills, both verbal and written.
  • Prior experience in a cleanroom environment preferred.
  • Ability to lift up to 30 lbs, sit for extended periods of time at a desk, or stand for extended periods.
  • Ability to comply with all Safety policies as applicable, including mandated personal protection equipment (PPE).
Travel Requirements:

up to 5%

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