Quality Engineer

Job 2539 - Quality Engineer - Contract located near Minneapolis, Minnesota

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

Onsite position

Scope

This Quality Engineer on the Field CAPA and Design Quality team will lead cross functional teams to determine actionable root cause and implement effective solutions for high visibility issues impacting Active Implantable Accessories product performance within our client's CRM division. This role is for a strong technical individual with an innate technical curiosity who is seeking leadership, complex problem-solving and project management experience. This individual will collaborate and partner with Research and Development, Regulatory, Marketing, Medical Safety, Manufacturing, Post Market and other Quality organizations to achieve optimal results. They will also support other Design Quality work and projects as required in the areas of risk management, new product development and sustainment.

Responsibilities Will Include

• Leads cross-functional teams on complex product performance investigations where suspected root cause is product design. Includes Nonconforming Events and Preventions (NCEPs), Corrective and Preventive Actions (CAPAs), and Field Action recommendations if applicable.
• Leads collaborative problem solving of complex technical issues using disciplined methodical techniques. Tools used include DMAIC, Root Cause Analysis (5 Whys, Cause and Effect Diagrams, and Is-Is Not).
• Creates, maintains and enhances cross-functional team partnerships.
• Provides guidance regarding technical strategies and approaches, works cross-functionally and across multiple sites in identifying and resolving technical issues.
• Represents the team at key global and divisional leadership forums.
• Creates and maintains detailed investigation documentation following Good Documentation Practice guidelines.
• Creates, reviews and approves Quality System records for NCEPs and CAPAs.
• Presents updates in formal and informal reviews with all levels of the organization including high senior leadership at our client.
• Mentors and guides other cross-functional teams and engineers by providing technical guidance and consulting on execution of NCEPs and CAPAs.
• May include consulting across other client divisions.
• Focuses on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations.
• Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Monitors and ensures compliance with company policies and procedures.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Systems.
  
  

Responsibilities

Build Quality into all aspects of their work by maintaining compliance to all quality requirements. Quality Policy and all other documented quality processes and procedures.

Minimum Qualifications

• Bachelor's degree in an engineering or related discipline plus 4 years of relevant experience
• Knowledgeable in Quality System Regulations, Medical Device Regulation and ISO 13485 Quality Standards.
• Experience in Medical Device industry
• Experience with non-conforming products/processes, CAPAs, Field Action, decision making and other investigation processes.
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint and Outlook.
  
  

Preferred Qualifications

• Experience with Active Implantable medical technologies
• Demonstrated technical problem-solving data analysis capabilities
• Experience with statistics and statistical analysis tools e.g. MINITAB, Weibull
• Strong ability to successfully multi-task and demonstrate adaptability
• Project management experience, direct or cross-functional teams
• Strong business acumen and communication skills with the ability to quickly establish impact and consequences
• Ability to collaborate and influence across multiple cross-functional teams
• Demonstrated experience managing and leading multiple projects covering diverse engineering i.e. Software, Hardware, Labeling disciplines and functions.
• Self-starter with the ability to identify improvement opportunities.
• Comfort speaking to groups of individuals including divisional senior leaders.
  
  

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

• Sponsorship is not available for this position
  
  

Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.