Quality Engineer
Onsite in Mansfield MA
M-F normal business hours
potential temp to perm
experience with handling complaints vs investigating.
Looking for mid level QE
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.
Justification for this role:
To answer your question:
- 72% of ILS-MAN complaints (421/585) are overdue.
- As a result, we are out of compliance with CFR §820.198(a)(1).
EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."