What are the responsibilities and job description for the Quality Engineer position at Medical Engineering Consultants (MEC)?
Job 2793 - 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.
Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.
Hybrid
About This Role
This quality engineer role will investigate product complaints and monitor our Client's product performance.
The team uses product performance data and deep dive analysis to understand if products are performing as intended. Escalating post-market field performance signals to better understand what the data is telling us collaborating with cross functional teams to mitigate risk focusing on patient safety and improving product performance.
Your Responsibilities May Include
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.
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.
Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.
Hybrid
About This Role
This quality engineer role will investigate product complaints and monitor our Client's product performance.
The team uses product performance data and deep dive analysis to understand if products are performing as intended. Escalating post-market field performance signals to better understand what the data is telling us collaborating with cross functional teams to mitigate risk focusing on patient safety and improving product performance.
Your Responsibilities May Include
- Embodying our Client's Core Values of Caring, Meaningful Innovation, High Performance, Global Collaboration, Diversity and Winning Spirit.
- Reviewing completed returned product lab analysis customer feedback and historical data to identify proper coding for product complaints.
- Performing complaint investigations in accordance with local and global processes.
- Analyzing post market surveillance data for patterns and trends and investigating when necessary. May be responsible for querying bounding data to support implementation of document releases.
- Responding to Competent Authority Requests.
- Communicating product performance by formal presentations to management committees and design teams, supporting published product performance reports and customer requests for performance information either directly or through the sales organization.
- Providing input for process improvement and helping develop tactical approaches to implement team strategies.
- Perform data analysis for Product Performance and Risk Management documentation by applying statistical methods and software.
- May be asked to engage in projects/project plans outlining work plans including timelines roles and resources Identifies and leads cross-functional project teams comprised of functional experts and local managers.
- Open and flexible to change in responsibilities taking on new engineering tasks and new product lines as the department grows and evolves.
- Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. - Investigates and reviews electronic circuits and components.
- Analyzes returned products to address complaints.
- Assist Lab Technicians during complaint investigations to ensure accurate and compliant product analysis and documentation.
- Review completed product analysis to ensure field allegations are adequately addressed.
- -Bachelor's degree or higher in Electrical or Biomedical Engineering
- BS with 1-3 years of relevant experience.
- Must have an electrical background
- A strong desire to be a part of a team that looks to make a difference each day to collectively solve problems.
- Understanding and a command of highly technical engineering topics and applied statistics.
- Ability to independently manage project work to define and consistently meet delivery dates.
- Understanding and experience operating within quality system processes and procedures.
- Strengths in communication verbal and written and data analysis skills.
- Engineering Degree with 2-3 years of relevant medical device experience.
- Experience in physical device analysis.
- Strong technical understanding of medical device therapy products.
- Significant participation in the Hazard Analysis and Risk Assessment as related to trend management.
- Strong Technical Writing skills.
- Experience with the quality system escalations CAPA investigations and field assessments.
- Strong understanding of the medical device regulatory requirements of post-market complaint tracking trending and analysis.
- Project experience and/or collaboration with Medical Safety Design Assurance Return Product Analysis Supplier Development and Manufacturing.
- Sponsorship is not available for this position
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.