Supplier Quality Control Manager

6 days ago


West Allis, Wisconsin, United States Softworld Inc Full time
Job Summary

Softworld Inc is seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our quality management team, you will be responsible for ensuring the highest standards of quality in our products and services.

Key Responsibilities
  • Participate in all applicable Quality Management System (QMS) activities, including document change management, records management, training/competency, non-conforming material reports (NCMRs), Complaint/Incident investigations and Corrective and Preventive Actions (CAPAs)
  • Collaborate with quality members in the product development processes and documentation, including supplier new product qualification and supplier development process
  • Execute tasks associated with continuous improvement activities
  • Provide data for predefined metrics for supplier monitoring
  • Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Ensure compliance with internal and external regulatory agencies
  • Facilitate accurate and timely completion of customer and quality records
  • Ensure that supplier corrective measures meet acceptable standards
  • Apply statistical methodologies for assessment and to resolve potential product and quality system issues
  • Lead small projects within the team or across one to two departments
  • Work independently, with minimal daily direction required to successfully develop deliverables
  • Lead qualification of supplier selection and approval process
  • Guide, supervise, and/or coach others on the quality team, may supervise a team
  • Create and maintain project schedules and delivery milestones for completion
Requirements
  • Bachelor's degree in engineering or life sciences required
  • Minimum 8 years Quality Engineering experience OR advanced degree with 5 years of applicable experience
  • Experience with ISO 13485, 21 CFR Part 820, and Medical Device Good Documentation Practices
  • Experience guiding and coaching others
  • 3+ years of experience leading supplier quality management and new product development projects, experience improving and maintaining an effective Quality Management System
Preferred Skills and Abilities
  • Proficient computer skills in MS Office Suite
  • Comprehensive understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
  • Strong analytical skills, including application of statistical techniques
  • Strict attention to detail
  • Strong technical writing skills and effective communication skills
  • Strong presentation, facilitation, and project management skills


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