Hybrid Design Quality Partner

Posted last month

Apply now

About the role

  • Ensure effective partnerships within Q&R and related functions
  • Enable project acceleration by efficient and timely milestone achievement
  • Enable an efficient document review process focusing on design control deliverables
  • Partner with the Strategic Quality Partner and stakeholders to ensure milestone readiness and achievement
  • Review and approve milestone deliverables within development projects
  • Represent Pre Market Quality in mQMS Communities of Practice
  • Support internal and external audits
  • Drive standardization of deliverables across projects and Customer areas
  • Ensure timely execution and quality process management for design change requests, NCs and CAPA
  • Model behavior to support and enable new ways of working and a culture of continuous improvement
  • Adopt Risk Enabler in decision making
  • Reduce complexity and drive continuous improvement across customer areas

Requirements

  • Bachelor's degree in Mechanical or Chemical Engineering or a related field
  • 3+ years of related experience
  • Strong design control/Quality Management System understanding
  • Knowledge and understanding of Quality and Regulatory requirements for review of design history file content
  • Knowledge of Regulations pertaining to the environment (i.e. ISO 13485, FDA, GMP, others)
  • Technical writing and data interpretation skills
  • Background in matrix-leadership for a global project team
  • Preferred Mandarin language proficiency is considered an advantage
  • Experience supporting the design and development of Hardware and Software systems and assay development is considered an advantage.
  • Experience working in a global setting is considered an advantage
  • MBA or advanced degree is considered an advantage

Benefits

  • A discretionary annual bonus may be available based on individual and Company performance

Job title

Design Quality Partner

Job type

Experience level

Mid levelSenior

Salary

$74,000 - $176,500 per year

Degree requirement

Bachelor's Degree

Location requirements

Report this job

See something inaccurate? Let us know and we'll update the listing.

Report job