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Senior Engineer-Quality

Regulatory and Quality Solutions LLC (R&Q) is the industry leader in providing regulatory and quality support to medical device companies.  From strategy to tactical implementation, R&Q partners with clients by providing business balanced solutions and hands-on support that enhance the commercialization and post market processes for medical devices.   Balancing the art and science of the regulatory and quality landscape has been the hallmark of R&Q’s mission and cemented it’s essence of the “and means more.” 

Being an industry leader in client support is just the beginning for R&Q.  Providing a rewarding place to work is rooted deep in the core values of R&Q.  From an industry leading compensation package to a deeply engrained focus on work life balance, R&Q applies the “and means more” approach to employment.  At R&Q, you are not just another employee, you are a member of the R&Q family. Make your impact today and join the Minnesota Team!

Job Summary: The Senior Engineer applies their knowledge to the delivery of regulatory and quality solutions to enable client success. The Senior Engineer delivers work products and executes the defined consulting scope of work with minimal oversight by experienced consultants. 

Depending on the individual client assignment(s), the Senior Engineer may perform the following essential duties:

  • Conducts Quality System Development programs as well as Quality System improvement programs with minimal supervision
  • Conducts quality audits and completes audit preparation of clients
  • Provides daily hands-on regulatory and quality support to clients under minimal supervision of an experienced consultant
  • Completes the drafting of worldwide regulatory strategies and worldwide regulatory submissions with minimal supervision
  • Conducts design assurance activities: safety risk management, usability, design verification and design validation with minimal supervision
  • Conducts process validation and other related quality manufacturing tasks with minimal supervision
  • Identifies supplier quality specifications and completes supplier qualification activities
  • Conducts supplier audits with supervision and direction from an experienced consultant
  • Conducts post-market surveillance activities including complaint/MDR handling, design history file remediation, and other remediation activities under minimal supervision

Project Lead/Support Responsibility

As a Lead ensure all projects are on schedule and hitting cost targets, profit margin, and are in compliance with the R&Q Quality Management System. Once the Business Development activity is complete (Contract signed), leads the customer to closure on the first project as well as pursues additional projects with the clients. Ensure the customer is 100% satisfied with the project, fully communicated with, and that any issues are predicted prior to them actually arising.  Must be able to understand the customer satisfaction level of the project at any given time. In a support role responsibilities are to complete work activities as defined by the project lead, on schedule and in accordance with the allotted hours. Communicates project risks and issues to the project lead in a timely fashion. 

Sales and Marketing

Identifies potential new customers, pursues conversations regarding R&Q capabilities, and creates connections for the Sales Team. Build relationships with customers and identifies new customer needs and requirements. Develops and cultivates a strong medical device industry network to provide connections to the Sales Team. Participate in marketing activities as assigned by the Marketing Team i.e. trade shows and R&Q hosted Industry events. 

Education/Work Experience

  • Bachelor level degree in engineering or chemistry, physics, biology or related life science 
  • 5-10 years related work experience
  • 3-7 years of experience in the medical device industry required
  • Consulting experience preferred

Additional Requirements

  • ​Must be willing to travel, up to 50%

Key Behaviors

Action-Oriented, Approachable, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

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