Quality Engineer II

Summary:
Primary function of the role is to address the backlog of Complaints that resulted from resource issues.
This role supports maintenance and continuous improvement of the Complaint System, ensuring compliance with regulations and internal site and global procedures.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:

• Ensure that all complaint investigations are performed, documented, and managed in a timely and efficient manner in accordance with all applicable internal procedures.
• Escalate relevant information on product complaints to appropriate management as necessary.
• Coordinate and/or attend meetings with appropriate departments for specific customer complaint issues.
• Plan, coordinate and execute the onboarding training of new complaint associates.
• Assess, process and close complaints in accordance with associated complaint handling procedures and Customer Quality expectations.
• Maintain and organize complaint product retention program at the investigation site in accordance with internal procedures and applicable regulatory requirements.
• Author and conduct technical complaint evaluations and investigations, including failure analysis.
• Review quality and manufacturing records, including DHRs, Company, CAPAs, complaint records, failure analysis data and reports, and risk documentation as part of the overall complaint investigation process.
• Perform trending and risk analysis of received complaint investigations; determine if upper controls have been exceeded and evaluate risk to patient.
• Perform robust root cause analysis using appropriate technical skills, structured problem-solving methods, etc.
• Review complaint evaluations and investigations, including failure analysis.
• Establish, follow, maintain, and improve Quality Management System procedures, work instructions, and other processes related to areas of responsibility.
• Support and participate in Internal and External Audits as required.
• Ensure compliance with ISO 13485, MDD, 21 CFR 820, GMP, and other applicable regulations and standards related to area of responsibility.
• Provide Complaints data analysis for metric reviews as applicable.
• Support and participate in post-market surveillance (PMS) activities as required.
• Identify and implement opportunities for continuous improvement.
• Perform other quality systems related duties as directed by Supervisor.

DESIRED MINIMUM QUALIFICATIONS

• Bachelor's degree in an Engineering discipline (ex. - Mechanical, Electrical, etc.) required with minimum of 2-5 years' experience in a regulated (i.e.- Medical Device) industry. Relevant experience may be considered in lieu of a degree.
• Strong knowledge of FDA Quality Systems Regulations, GMP, ISO 13485 and other global regulations and standards related to Complaints and Complaint Handling.
• Strong verbal and written communication skills with the ability to communicate effectively at multiple levels of the organization.
• Demonstrated organizational skills with the ability to multitask, prioritize and meet deadlines.
• Must be able to read and write in English.

Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.