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Nextern is hiring for the role Principal Global Quality Systems Engineer(link removed) This role comes with competitive pay and a full benefits package (details below)

The Principal Global Quality Systems Engineer will be responsible for maintaining and implementing Nexterns Global Quality System, specifically executing lean process improvements globally. This role will own the Corrective & Preventive Action process ensuring execution and compliance, execute Quality System software configuration and lead software validation of Quality System (QMS) tools. Execute as a lead auditor for internal/supplier audits.

DUTIES AND RESPONSIBILITIES:

• Lead and facilitate global QMS procedure changes and process improvements required to align business processes or changes to industry standards and requirements.
• Provide leadership, training, mentorship to users utilizing Quality System resources and tools
• Ensure adherence to Quality System procedures on a global and customer level
• Directly manage and ensure compliance of the Corrective & Preventive Action process
• Execute quality system software configuration of Agile PLM, eLMS, ERP
• Audit support including execution of the global internal audit program, customer audits and regulatory/notified body audits.
• Utilization of Project Management, Six Sigma, Lean or other disciplines to improve Quality System processes.
• Performs other related duties as assigned by management.

SUPERVISORY RESPONSIBILITIES:

• This job has no supervisory responsibilities. However, will work closely and mentor other employees to ensure compliance to Nextern procedures.

Requirements

QUALIFICATIONS:

• 10 years of relevant experience in ISO 13485 and FDA GMP or relevant experience aligns directly to the job specific responsibilities listed below:
• Agile PLM Java experience is required to manage configuration of Agile fields, workflows, and mass data uploads
• ISO13485 lead auditor certification
• Excellent skills in standard computer-based software programs such as Microsoft Office.
• Excellent learning agility.
• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
• Ability to effectively build and maintain relationships, communicate, and interact with a variety of personalities.
• Preferred Qualifications:
  • Microsoft Power BI report building
  • Epicor (ERP) reporting experience or other similar applications
  • Project management experience
  • Medical device industry experience

Benefits

Nextern offers excellent benefits to fuel you in building a fulfilling life & career:

• Employer subsidized health insurance for employees
• Employer paid dental insurance
• Employer HSA contribution
• 401k plan with a company match
• 9 paid holidays (including your birthday!) + PTO and Personal days
• Gym membership subsidy
• Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance