What are the responsibilities and job description for the Quality Engineer position at Medical Engineering Consultants (MEC)?
Job 2621 - Quality Engineer - Contract located in Los Angeles County
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
About This Role
Responsible for creating test methods, work instructions, training and mentoring technicians who work on investigation of return and not-return products. The QE will review result of investigations completed by others for accuracy, completeness and compliance to SOPs/WIs. The results of investigations can be used to escalate product issues in collaboration with other Post Market functions, R&D, Design Assurance, Operations, Supplier Management and Medical Safety.
Responsibilities Will 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.
Onsite
About This Role
Responsible for creating test methods, work instructions, training and mentoring technicians who work on investigation of return and not-return products. The QE will review result of investigations completed by others for accuracy, completeness and compliance to SOPs/WIs. The results of investigations can be used to escalate product issues in collaboration with other Post Market functions, R&D, Design Assurance, Operations, Supplier Management and Medical Safety.
Responsibilities Will Include
- Understanding failure modes and approving product analysis for return and non-return complaints related to mechanical medical devices performed by technicians
- Coordinating training and supervising failure investigation activities for lab technicians
- Support integration of new products into CIS lab by creating/validating test methods and test instructions
- Creating and presenting slides for SER/CRB
- Collaborating with other Post Market CCC/CMC teams, R&D, Design Assurance, Manufacturing, Supplier to help determine root cause of complaints
- Monitoring product performance and escalating any non-conformance issues with returned devices
- Creating/releasing new WI/SOPs in document control system
- Initiating and owning non-conformance investigations
- Training technicians to find root cause of complaints through sound failure analysis techniques
- Bachelor's degree in Mechanical Engineering with 2 years of relevant experience
- Bachelor's degree can be in electromechanical/electrical but the candidate needs to have hands-on experience in failure analysis.
- Demonstrated problem-solving, failure analysis, capabilities of mechanical systems/components
- Proficient with Microsoft Office tools including Word Excel PowerPoint and Outlook
- Great written/verbal communication skills and ability to collaborate with other teams
- Ability to successfully multi-task and be adaptive
- Master's degree in Mechanical Engineering with at least 1 year experience in similar role
- Ability to understand system level functionalities to devise and validate test methods for failure analysis of systems/components
- Experience in Medical Device industry
- Familiarity with Post Market requirements and systems
- Familiarity complaint systems used for medical devices
- Experience with using SAP and PowerBI
- 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.