SRG, the leader in the Life Sciences human capital industry, is looking for a Quality Engineer II - Complaints Investigator/Handler located in Mansfield, MA.

JOB RESPONSIBILITIES include, but are not limited to:

This role supports maintenance and continuous improvement of the Complaint System, ensuring compliance with regulations and internal site and global procedures.

• 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, NCs, 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.

WHAT YOU NEED TO HAVE:

• Bachelor's degree in an Engineering discipline (ex. - Mechanical, Electrical, etc.) required with minimum of 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.

** "SRG values your application, our team will be in touch to schedule interviews with candidates moving forward in the process."

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.