Job 2275-Design Quality 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.

Job Summary

Support the Quality Management System (QMS) organization. Work with design and manufacturing teams, completing operations quality activities. Assignments include use of quality engineering concepts including, but not limited to, design control, process control, risk management, supplier quality, root cause analysis, statistical analysis, and continuous improvement activities. Ensure desired design and product performance requirements are met in compliance with applicable regulatory, customer, and internal requirements. Skills in other technical areas such as verification testing, and sterilization validation are desired. Engage in routine daily activities such as First Article Inspections (FAI), CAPA, NCMR, change order review, and training.

Key Responsibilities

• Function as the operation’s quality lead during the execution of engineering projects.
• Responsible for ensuring product development projects and changes to existing products are conducted in compliance with the Quality System Regulations.
• Lead NCMR and CAPA investigation and reports. including assisting in trouble shooting manufacturing problems and ensuring requirement compliance. Collaborate with suppliers on NCMRs and suppler CAPAs.
• Participate in cross-functional teams for the review and disposition of nonconforming products or components as a quality lead.
• Participate in cross-functional teams to develop and assist in maintenance of Product Risk Management Files (Risk Management Plan, Risk Assessments, DFMEA, PFMEA, and Risk Management Report).
• Author and review documentation with a high degree of accuracy, completeness, and effectiveness.
• Lead in the development of Design Verification and Validation test plans / protocols and Process Verification and Validation test plans / protocols from a Quality perspective.
• Provide guidance on Product Requirements compliance.
• Provide guidance and direction for sample size and statistical analysis of Verification and Validation testing.
• Lead in Design Reviews and FMEA Reviews.
• Lead in complaint investigation. Ensure investigations are thoroughly documented.
• Provide direction to project teams on all Quality Policies / Procedures (including verification, validation, statistical methods, and design controls), as necessary.
• Provide training of Special Work Orders, Receiving Inspection Processes, and FAIs as required
• Other duties as assigned.
  
  

Qualifications

• Requires a B.S. degree in Science, Engineering or Technology or associated fields.
• Working knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971).
• Working knowledge of new product design and development in medical devices.
• Working knowledge of the application of risk management, include PFMEA.
• Excellent organizational and interpersonal skills working in a cross-functional teams.
• Ability to organize and prioritize workflow across multiple projects to meet established time frames and schedules.
• Knowledge of manufacturing operations, process verification and validation, and geometric design and tolerance (GD&T) including the ability to read and understand prints and specifications
• 5+ years’ experience in Quality Assurance, including quality systems, standards, metrics, and tools.
• 5+ years’ experience in the medical device industry.
  
  

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.