Job Description

Precipart is looking to hire a Quality Systems Engineer to join our Quality Management Systems Team. As a Quality Systems Engineer you will be instrumental in accurately and effectively supporting the management of the ISO Quality System. This position specifically focuses on customer satisfaction; we are looking for someone who will work diligently to resolve customer concerns, support new program development and drive opportunities for improvement through internal and external audits. Responsibilities

• Maintain and continuously improve the Quality Management System
  • As per ISO 13485, ISO 9001 and AS9100 standards.
  • Provide support to management representative for company ISO/AS registration.
  • Track and trend company data relevant to scorecard metrics.
  • Maintain quality systems data that will track, monitor and steer the department objectives; create meaningful summary reports.
  • Revise and review quality-related documents.
• Resolve Customer Concerns (as delegated by QS Assoc. Dir.)
  • Assist in quality investigations with customers. Track complaints through to satisfactory completion.
  • Assist with internal quality investigations. Proactively determine where the quality system did not meet requirements.
  • Identify and implement appropriate corrective actions to resolve all concerns to the satisfaction of ISO/AS, company and customer requirements.
  • Establish and maintain corrective action system records.
• Supplier Development (as delegated by QS Assoc. Dir.)
  • Assist suppliers with root cause analysis.
  • Track supplier development from initial qualification through formal approval.
  • Monitor supplier performance and provide feedback.
  • Establish and maintain supplier files/records.
• Auditing
  • Prepare and execute internal process audits in accordance with ISO 13485, ISO 9001 and AS 9100 requirements.
  • Prepare and execute supplier audits in accordance with internal procedures and work instructions.
  • Support customer audits (on-site and/or remote).
• Provide technical service support to all product lines (medical, industrial and aerospace).
  • Prepare and track customer documentation requirements, including sample submissions, inspection plans, specifications, quality agreements, customer quality system surveys and regulatory compliance.
  • Support the Sales and Program Management teams with respect to contract review requirements.
• Responsible for conforming with the company s quality management system requirements, as well as contributing to its overall effectiveness, and the ultimate goals of customer satisfaction, product compliance and ethical practices/behavior.
• Perform other duties as assigned.

Requirements

• Bachelor s degree in Engineering field (Mechanical or Biomedical preferred)
• Strong problem solving and analytical skills
• Detail oriented, highly organized; able to multi-task and prioritize workload
• Interpersonal effectiveness with internal team members, customers and suppliers
• Proficient in Microsoft Office applications (Outlook, Word, Excel, Access and PowerPoint)
• 2 year of experience working in quality or medical field preferred
• Auditing experience preferred

What We ll Offer You in Return

• Base salary plus incentive program
• Paid time off
• Medical, dental, vision insurance
• Flexible Spending Account
• Health Saving Account
• Life insurance, enhanced short term and long-term disability insurance
• 401k Profit sharing plan
• Education Assistance Program
• National Employee Assistance Program
• 529 College Savings Program
• Professional development and training
• Brand new, modern workspace and manufacturing facilities
• Company events and outings, from Employee Appreciation Day to professional sports games
• Stable organization with opportunities for future growth within the company

About Precipart Precipart engineers, designs and manufactures high precision custom solutions for the world s leading companies in the Medical, Aerospace and Industrial markets. We act as a partner across your entire manufacturing process by engineering precision gears, mechanical components, assemblies and motion control solutions, as well as delivering end-to-end capabilities and more. With offices in Switzerland, the U.S. and U.K, we are here to help you engineer possible .