Principal Quality Management Systems Engineer

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.

About The Role

Create and update quality system documentation as required to ensure continuous improvement is occurring and that best practices are institutionalized. Develop and conduct associated training as required.

Role And Responsibility

• Provide quality engineering support to the project teams to ensure QMS SOP’s are followed and implemented as intended in a consistent manner.
• Identify and manage risk throughout the development process or assist and coach Design Quality Engineers and ensure risk analysis for all products is completed and maintained using ISO 14971.
• Coordinate the development of an FMEA when applicable.
• Participate in the design, development, and prototyping of new devices, components and processes to meet the customer needs, lower costs and improve the quality of the product as required.
• Assist and coach Design Quality Engineers to design and develop new test methods and equipment
• Assist and coach Manufacturing Quality Engineers in creation and improvement of manufacturing processes, process validations, and design transfer.
• Coach all Quality Engineers related to risk management, statistical methods, problem solving, sterilization and related topics, and other activities.
• Coordinate, review and approve design verification and validation plans as needed.
• Review and approve all associated protocols and reports to ensure they meet the intended purpose.
• Ensure testing is sufficient to meet regulatory requirements and quality objectives.
• Ensure that deliverable requirements are received, filed and maintained in the DHF/Technical File.
• Ensure selected design components are qualified per internal documented requirements.
• Ensure selected suppliers are approved per requirements.
• Ensure incoming inspection, in-process inspection, quality inspection, and final product test requirements are defined and implemented to the rigor level required per defined risk levels.
• Manage corrective action activities, when required, and ensure the activities are thoroughly investigated, implemented, effective, and completed in a timely manner.
• Participate in internal and external quality audits as needed.
• Review and approve deviations and/or document change requests and generate as needed.
• Participate in manufacturing transfer planning and implementation.
• Ensure all finished goods meet established customer and company quality standards.
• Ensure manufacturing activities are conducted as required and associated paperwork is completed correctly and completely.
• Ensure all appropriate records are maintained.
• When needed, author protocols and procedures for the testing, qualification, validation of product and processes.
  
  

Technical Skills

• Understanding of ISO 13485 and FDA QSR requirements including design controls, manufacturing operations, and risk management.
• Demonstrated ability to implement, execute, and maintain quality system policies and procedures.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Highly proficient with MS Office (Word, Excel, Access and PowerPoint), internet and e-mail systems.
• Solid understanding of software capabilities and business applications.
• Ability to accurately prioritize and execute with minimal direction.
• Ability to interpret and understand drawing specifications, tolerances, procedures for inspection and the application of sampling plans.
• Broad knowledge of theory and principles of statistics and statistical process control.
• Diverse knowledge of inspection and control methods, techniques and documentation.
• Excellent communication skills (written and verbal).
• Bachelor's Degree in Stem Field
• Higher Level Degrees, such as MBA preferred
• Med Device experience 10 years total, familiarity with Switchback product types preferred
• 5 -7 of the 10 years of experience in quality, 5 years specifically with QMS development
  
  

Conceptual Skills

• Creative problem solver coupled with good judgment.
• Independent work skills.
• High attention to detail and accuracy.
• Ability to manage, prioritize and execute multiple tasks.
• Positive, flexible outlook.
• Dependable.
• Strong interpersonal communication skills with the ability to effectively communicate across all levels.
• Ability to coach and develop personnel.
• Proven ability to work effectively alone and in a multi-disciplinary team.
• Presents professional manner and appearance.
  
  

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.